New Drug Approvals Archive for 2017

Bydureon BCise (exenatide) Extended-Release Injectable Suspension

Date of Approval: October 20, 2017
Company: AstraZeneca
Treatment for: Diabetes, Type 2

Bydureon BCise (exenatide) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in patients with type 2 diabetes.

• FDA Approves Bydureon - The First and Only Once-Weekly Treatment for Type 2 Diabetes
• Bydureon BCise (exenatide) FDA Approval History

Arymo ER (morphine sulfate) Extended-Release Tablets

Date of Approval: January 9, 2017
Company: Egalet Corporation
Treatment for: Pain

Marketing Status: Discontinued

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation for the management of severe pain.

• FDA Approves Arymo ER (morphine sulfate) Abuse-Deterrent Formulation for the Treatment of Chronic Pain
• Arymo ER (morphine sulfate) FDA Approval History

Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

Date of Approval: January 17, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Pain

Marketing Status: Discontinued

Vantrela ER (hydrocodone bitartrate) is an abuse deterrent opioid formulation for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.

• Teva Receives FDA Approval for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets Formulated with Proprietary Abuse Deterrence Technology
• Vantrela ER (hydrocodone bitartrate) FDA Approval History

Trulance (plecanatide) Tablets

Date of Approval: January 19, 2017
Company: Synergy Pharmaceuticals Inc.
Treatment for: Constipation, Chronic, Irritable Bowel Syndrome

Trulance (plecanatide) is a guanylate cyclase-C agonist for the treatment of chronic idiopathic constipation, and irritable bowel syndrome with constipation (IBS-C).

• FDA Approves Trulance (plecanatide) for Chronic Idiopathic Constipation
• Trulance (plecanatide) FDA Approval History

Rhofade (oxymetazoline hydrochloride) Cream

Date of Approval: January 18, 2017
Company: Allergan plc
Treatment for: Rosacea

Rhofade (oxymetazoline hydrochloride) is a topical alpha_1A adrenoceptor agonist vasoconstrictor for the treatment of persistent facial erythema associated with rosacea in adults.

• Allergan Announces FDA Approval of Rhofade (oxymetazoline hydrochloride) Cream for Facial Erythema Associated with Rosacea
• Rhofade (oxymetazoline hydrochloride) FDA Approval History

AirDuo RespiClick (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

AirDuo RespiClick (fluticasone propionate and salmeterol) is a corticosteroid and long-acting beta₂-adrenergic agonist (LABA) combination in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

• Teva Announces FDA Approval of AirDuo RespiClick (fluticasone propionate and salmeterol) for Maintenance Treatment of Asthma
• AirDuo RespiClick (fluticasone propionate and salmeterol) FDA Approval History

ArmonAir RespiClick (fluticasone propionate) Inhalation Powder

Date of Approval: January 27, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma, Maintenance

ArmonAir RespiClick (fluticasone propionate) is an inhaled corticosteroid in a breath-activated, multi-dose dry powder inhaler formulation for the treatment of asthma.

• Teva Announces FDA Approval of ArmonAir RespiClick (fluticasone propionate) for Maintenance Treatment of Asthma
• ArmonAir RespiClick (fluticasone propionate) FDA Approval History

Parsabiv (etelcalcetide) Injection

Date of Approval: February 7, 2017
Company: Amgen Inc.
Treatment for: Secondary Hyperparathyroidism

Parsabiv (etelcalcetide) is a calcium-sensing receptor agonist indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.

• FDA Approves Amgen's Parsabiv (etelcalcetide) for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
• Parsabiv (etelcalcetide) FDA Approval History

Emflaza (deflazacort) Tablets and Oral Suspension

Date of Approval: February 9, 2017
Company: PTC Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Emflaza (deflazacort) is a glucocorticoid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.

• FDA Approves Emflaza (deflazacort) to treat Duchenne Muscular Dystrophy
• Emflaza (deflazacort) FDA Approval History

Siliq (brodalumab) Injection

Date of Approval: February 15, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Plaque Psoriasis

Siliq (brodalumab) is a human anti-interleukin-17-receptor monoclonal antibody for the treatment of plaque psoriasis.

• FDA Approves Siliq (brodalumab) for Plaque Psoriasis
• Siliq (brodalumab) FDA Approval History

Qtern (dapagliflozin and saxagliptin) Tablets

Date of Approval: February 27, 2017
Company: AstraZeneca
Treatment for: Diabetes, Type 2

Qtern (dapagliflozin and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor fixed-dose combination for the treatment of adult patients with type 2 diabetes.

• FDA Approves Once-Daily Qtern (dapagliflozin and saxagliptin) Tablets for Adults with Type-2 Diabetes
• Qtern (dapagliflozin and saxagliptin) FDA Approval History

Xermelo (telotristat ethyl) Tablets

Date of Approval: February 28, 2017
Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome Diarrhea

Xermelo (telotristat ethyl) is an oral tryptophan hydroxylase inhibitor indicated for use in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors.

• FDA Approves Xermelo (telotristat ethyl) as First and Only Oral Treatment for Carcinoid Syndrome Diarrhea in Cancer Patients with Metastatic Neuroendocrine Tumors
• Xermelo (telotristat ethyl) FDA Approval History

Odactra (house dust mite allergen extract) Sublingual Tablets

Date of Approval: March 1, 2017
Company: ALK-Abelló A/S
Treatment for: House Dust Mite Allergies

Odactra (house dust mite allergen extract) is a sublingual allergy immunotherapy (SLIT) tablet indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis.

• FDA Approves Odactra for House Dust Mite Allergies
• Odactra (house dust mite allergen extract) FDA Approval History

Noctiva (desmopressin acetate) Nasal Spray

Date of Approval: March 3, 2017
Company: Serenity Pharmaceuticals, LLC
Treatment for: Nocturia

Noctiva (desmopressin acetate) is vasopressin analog nasal spray indicated for the treatment of nocturia due to nocturnal polyuria.

• FDA Approves Noctiva (desmopressin acetate) Nasal Spray for Nocturia in Adults
• Noctiva (desmopressin acetate) FDA Approval History

Kisqali (ribociclib) Tablets

Date of Approval: March 13, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Breast Cancer

Kisqali (ribociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6 used for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

• FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer
• Kisqali (ribociclib) FDA Approval History

Xadago (safinamide) Tablets

Date of Approval: March 21, 2017
Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

• FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease
• Xadago (safinamide) FDA Approval History

Bavencio (avelumab) Injection

Date of Approval: March 23, 2017
Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma, Urothelial Carcinoma, Renal Cell Carcinoma

Bavencio (avelumab) is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of patients with metastatic Merkel cell carcinoma (MCC); patients with advanced or metastatic urothelial carcinoma; and in combination with axitinib for patients with advanced renal cell carcinoma.

• FDA Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma
• Bavencio (avelumab) FDA Approval History

Symproic (naldemedine) Tablets

Date of Approval: March 23, 2017
Company: Shionogi Inc.
Treatment for: Opioid-Induced Constipation

Symproic (naldemedine) is a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation.

• FDA Approves Symproic (naldemedine) for the Treatment of Opioid-Induced Constipation
• Symproic (naldemedine) FDA Approval History

Zejula (niraparib) Capsules and Tablets

Date of Approval: March 27, 2017
Company: GSK
Treatment for: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Zejula (niraparib) is an oral, poly ADP-ribose polymerase (PARP) inhibitor for the treatment of patients with ovarian, fallopian tube, or primary peritoneal cancer.

• Tesaro Announces FDA Approval of Zejula (niraparib) for Women with Recurrent Ovarian Cancer
• Zejula (niraparib) FDA Approval History

Dupixent (dupilumab) Injection

Date of Approval: March 28, 2017
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis, Asthma, Chronic Rhinosinusitis With Nasal Polyps, Eosinophilic Esophagitis, Prurigo Nodularis, COPD

Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist used for the treatment of atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease (COPD).

• FDA Approves Dupixent (dupilumab) for Eczema
• Dupixent (dupilumab) FDA Approval History

Ocrevus (ocrelizumab) Injection

Date of Approval: March 28, 2017
Company: Genentech, Inc.
Treatment for: Multiple Sclerosis

Ocrevus (ocrelizumab) is a humanized monoclonal antibody designed to selectively target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin and axonal nerve cell damage. Ocrevus is indicated as a treatment for both relapsing (RMS) and primary progressive (PPMS) forms of multiple sclerosis.

• FDA Approves Ocrevus (ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
• Ocrevus (ocrelizumab) FDA Approval History

Austedo (deutetrabenazine) Tablets - formerly SD-809

Date of Approval: April 3, 2017
Company: Teva Pharmaceutical Industries Ltd.
Treatment for: Huntington's Disease, Tardive Dyskinesia

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia.

• Teva Announces FDA Approval of Austedo (deutetrabenazine) for the Treatment of Chorea Associated with Huntington’s Disease
• Austedo (deutetrabenazine) FDA Approval History

Ingrezza (valbenazine) Capsules and Sprinkle Capsules

Date of Approval: April 11, 2017
Company: Neurocrine Biosciences, Inc.
Treatment for: Tardive Dyskinesia, Huntington's Disease

Ingrezza (valbenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease.

• Neurocrine Announces FDA Approval of Ingrezza (valbenazine) as the First and Only Approved Treatment for Adults with Tardive Dyskinesia (TD)
• Ingrezza (valbenazine) FDA Approval History

Renflexis (infliximab-abda) Injection

Date of Approval: April 21, 2017
Company: Samsung Bioepis Co., Ltd.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Renflexis (infliximab-abda) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

• FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
• Renflexis (infliximab-abda) FDA Approval History

RoxyBond (oxycodone hydrochloride) Tablets

Date of Approval: April 20, 2017
Company: Protega Pharmaceuticals LLC
Treatment for: Pain

RoxyBond (oxycodone hydrochloride) is an immediate-release, abuse-deterrent, narcotic analgesic formulation for the management of severe pain.

• Inspirion Delivery Sciences Receives FDA Approval for RoxyBond (oxycodone hydrochloride) Immediate Release Tablets with Abuse-Deterrent Label Claims
• RoxyBond (oxycodone hydrochloride) FDA Approval History

Xatmep (methotrexate) Oral Solution

Date of Approval: April 25, 2017
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Acute Lymphoblastic Leukemia, Juvenile Idiopathic Arthritis

Xatmep (methotrexate) is a folate analog metabolic inhibitor in an oral solution formulation indicated for the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and for the management of pediatric patients with active polyarticular juvenile idiopathic arthritis.

• FDA Approves Xatmep (methotrexate) Oral Solution
• Xatmep (methotrexate) FDA Approval History

Brineura (cerliponase alfa) Injection

Date of Approval: April 27, 2017
Company: BioMarin Pharmaceutical Inc.
Treatment for: CLN2 Disease

Brineura (cerliponase alfa) is an enzyme replacement therapy for the restoration of tripeptidyl peptidase-1 (TPP1) enzyme activity in patients with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), or TPP1 deficiency, a form of Batten disease.

• FDA Approves Brineura (cerliponase alfa) for CLN2 Disease, a Form of Batten Disease
• Brineura (cerliponase alfa) FDA Approval History

Rydapt (midostaurin) Capsules - formerly PKC412

Date of Approval: April 28, 2017
Company: Novartis
Treatment for: Acute Myeloid Leukemia, Systemic Mastocytosis

Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.

• FDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis
• Rydapt (midostaurin) FDA Approval History

Tymlos (abaloparatide) Injection

Date of Approval: April 28, 2017
Company: Radius Health, Inc.
Treatment for: Osteoporosis

Tymlos (abaloparatide) is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) for the treatment of osteoporosis.

• FDA Approves Tymlos (abaloparatide) for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture
• Tymlos (abaloparatide) FDA Approval History

Alunbrig (brigatinib) Tablets

Date of Approval: April 28, 2017
Company: Takeda Pharmaceutical Company Limited
Treatment for: Non Small Cell Lung Cancer

Alunbrig (brigatinib) is an anaplastic lymphoma kinase (ALK) inhibitor for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

• Takeda Announces FDA Accelerated Approval of Alunbrig (brigatinib)
• Alunbrig (brigatinib) FDA Approval History

Imfinzi (durvalumab) Injection

Date of Approval: May 1, 2017
Company: AstraZeneca
Treatment for: Non Small Cell Lung Cancer, Small Cell Lung Cancer, Biliary Tract Tumor, Hepatocellular Carcinoma, Endometrial Cancer

Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody used for the treatment of non-small cell lung cancer, small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, and endometrial cancer.

• AstraZeneca’s Imfinzi (durvalumab) Receives FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer
• Imfinzi (durvalumab) FDA Approval History

Radicava (edaravone) Injection

Date of Approval: May 5, 2017
Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Radicava (edaravone) is a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.

• FDA Approves Radicava (edaravone) to Treat Amyotrophic Lateral Sclerosis (ALS)
• Radicava (edaravone) FDA Approval History

Kevzara (sarilumab) Injection

Date of Approval: May 22, 2017
Company: Sanofi and Regeneron Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Polymyalgia Rheumatica, Polyarticular Juvenile Idiopathic Arthritis

Kevzara (sarilumab) is an interleukin-6 (IL-6) receptor antagonist for the treatment of rheumatoid arthritis, polymyalgia rheumatica and polyarticular juvenile idiopathic arthritis.

• Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis
• Kevzara (sarilumab) FDA Approval History

Rebinyn (coagulation factor IX (recombinant), glycopegylated) Injection

Date of Approval: May 31, 2017
Company: Novo Nordisk
Treatment for: Hemophilia B

Rebinyn (coagulation factor IX (recombinant), glycoPEGylated) is an extended-half-life, recombinant DNA-derived coagulation factor IX concentrate used in the management of bleeding episodes in patients with hemophilia B.

• FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B
• Rebinyn (coagulation factor IX (recombinant), glycopegylated) FDA Approval History

Zerviate (cetirizine hydrochloride) Ophthalmic Solution

Date of Approval: May 30, 2017
Company: Nicox S.A.
Treatment for: Conjunctivitis, Allergic

Zerviate (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist ophthalmic formulation for the treatment of ocular itching associated with allergic conjunctivitis.

• Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24%
• Zerviate (cetirizine hydrochloride) FDA Approval History

Gleolan (aminolevulinic acid hydrochloride) Oral Solution

Date of Approval: June 6, 2017
Company: NX Development Corp.
Treatment for: Optical Imaging During Glioma Surgery

Gleolan (aminolevulinic acid hydrochloride) is an optical imaging agent indicated for use in patients with glioma as an adjunct for the visualization of malignant tissue during surgery.

• FDA Approves Gleolan (aminolevulinic acid hydrochloride) as an Optical Imaging Agent in Patients with Gliomas
• Gleolan (aminolevulinic acid hydrochloride) FDA Approval History

Symjepi (epinephrine) Injection

Date of Approval: June 15, 2017
Company: Adamis Pharmaceuticals Corporation
Treatment for: Allergic Reactions

Symjepi (epinephrine) is a non-selective alpha and betaadrenergic receptor agonist in a single-dose, pre-filled syringe for use the emergency treatment of allergic reactions (Type I) including anaphylaxis.

• Adamis Pharmaceuticals Receives FDA Approval for Symjepi (epinephrine) Pre-Filled Syringe
• Symjepi (epinephrine) FDA Approval History

Baxdela (delafloxacin) Tablets and Injection

Date of Approval: June 19, 2017
Company: Melinta Therapeutics
Treatment for: Skin and Structure Infection, Pneumonia

Baxdela (delafloxacin) is a fluoroquinolone antibacterial indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) caused by designated susceptible bacteria.

• Melinta Therapeutics Announces FDA Approval of Baxdela (delafloxacin) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
• Baxdela (delafloxacin) FDA Approval History

Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets

Date of Approval: June 19, 2017
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

Cotempla XR-ODT (methylphenidate) is a once-daily, extended-release, orally disintegrating tablet formulation of the central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

• Neos Therapeutics Announces FDA Approval of Cotempla XR-ODT (methylphenidate) Extended-Release Orally Disintegrating Tablets for the Treatment of ADHD in Patients 6 to 17 Years Old
• Cotempla XR-ODT (methylphenidate) FDA Approval History

Mydayis (amphetamine mixed salts)

Date of Approval: June 20, 2017
Company: Shire plc
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Mydayis (amphetamine mixed salts) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

• FDA Approves Mydayis (mixed salts of a single-entity amphetamine product) – A New Once-Daily Option for ADHD
• Mydayis (amphetamine mixed salts) FDA Approval History

Rituxan Hycela (rituximab and hyaluronidase human) Injection

Date of Approval: June 22, 2017
Company: Genentech, Inc.
Treatment for: Follicular Lymphoma; Diffuse Large B-Cell Lymphoma; Chronic Lymphocytic Leukemia

Rituxan Hycela (rituximab and hyaluronidase human) is a subcutaneous monoclonal antibody and hyaluronidase human formulation for the treatment of adult patients with follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).

• FDA Approves Rituxan Hycela (rituximab and hyaluronidase human) for Subcutaneous Injection in Certain Blood Cancers
• Rituxan Hycela (rituximab and hyaluronidase human) FDA Approval History

Haegarda (C1 esterase inhibitor (human)) Subcutaneous Injection - formerly CSL830

Date of Approval: June 22, 2017
Company: CSL Behring
Treatment for: Hereditary Angioedema

Haegarda (C1 esterase inhibitor (human)) is a low-volume subcutaneous (SC) C1-esterase inhibitor (C1-INH) replacement therapy for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older.

• FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema
• Haegarda (C1 esterase inhibitor (human)) FDA Approval History

Bevyxxa (betrixaban) Capsules

Date of Approval: June 23, 2017
Company: Portola Pharmaceuticals Inc.
Treatment for: Prevention of Venous Thromboembolism

Bevyxxa (betrixaban) is an oral, once-daily Factor Xa inhibitor anticoagulant for the extended-duration prophylaxis of venous thromboembolism (VTE) in at-risk adult patients hospitalized for an acute medical illness.

• FDA Approves Bevyxxa (betrixaban) for Hospital and Extended Duration Prevention of Venous Thromboembolism (VTE) in Acutely Ill Medical Patients
• Bevyxxa (betrixaban) FDA Approval History

Triptodur (triptorelin) Injection

Date of Approval: June 29, 2017
Company: Azurity Pharmaceuticals, Inc.
Treatment for: Precocious Puberty

Triptodur (triptorelin) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty.

• Arbor Pharmaceuticals, LLC Announces FDA Approval for Triptodur (triptorelin)
• Triptodur (triptorelin) FDA Approval History

Endari (L-glutamine) Oral Powder

Date of Approval: July 7, 2017
Company: Emmaus Life Sciences Inc.
Treatment for: Sickle Cell Anemia

Endari (L-glutamine) is orally-administered pharmaceutical grade L-glutamine (PGLG), an amino acid formulation to relieve pain, swelling and other complications of sickle cell anemia.

• FDA Approves Endari (L-glutamine oral powder) for Sickle Cell Disease
• Endari (L-glutamine) FDA Approval History

Tremfya (guselkumab) Injection

Date of Approval: July 13, 2017
Company: Janssen Biotech, Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Ulcerative Colitis

Tremfya (guselkumab) is an interleukin-23 blocker for the treatment of plaque psoriasis, psoriatic arthritis and ulcerative colitis.

• Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis
• Tremfya (guselkumab) FDA Approval History

Nerlynx (neratinib) Tablets

Date of Approval: July 17, 2017
Company: Puma Biotechnology, Inc.
Treatment for: Breast Cancer

Nerlynx (neratinib) is a tyrosine kinase inhibitor indicated:

• as a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
• in combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting.

• FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer
• Nerlynx (neratinib) FDA Approval History

Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Tablets

Date of Approval: July 18, 2017
Company: Gilead Sciences, Inc.
Treatment for: Hepatitis C

Vosevi (sofosbuvir, velpatasvir and voxilaprevir or SOF/VEL/VOX) is a fixed-dose combination of a nucleotide analog NS5B polymerase inhibitor (SOF), a pangenotypic NS5A inhibitor (VEL), and a pangenotypic NS3/4A protease inhibitor (VOX) for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.

• FDA Approves Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for Re-Treatment of Adults with Chronic Hepatitis C Virus
• Vosevi (sofosbuvir, velpatasvir and voxilaprevir) FDA Approval History

Idhifa (enasidenib) Tablets

Date of Approval: August 1, 2017
Company: Celgene Corporation
Treatment for: Acute Myeloid Leukemia

Idhifa (enasidenib) is a first-in-class, oral, targeted inhibitor of mutant isocitrate dehydrogenase 2 (IDH2) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation.

• FDA Approves Idhifa (enasidenib) for Relapsed or Refractory Acute Myeloid Leukemia with IDH2 Mutation
• Idhifa (enasidenib) FDA Approval History

Vyxeos (cytarabine and daunorubicin) Injection

Date of Approval: August 3, 2017
Company: Jazz Pharmaceuticals plc
Treatment for: Acute Myeloid Leukemia

Vyxeos (cytarabine and daunorubicin liposome injection) is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor, and daunorubicin, an anthracycline topoisomerase inhibitor, indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.

• FDA Approves Vyxeos (daunorubicin and cytarabine) Liposome for Injection for Certain Types of Poor-Prognosis Acute Myeloid Leukemia
• Vyxeos (cytarabine and daunorubicin) FDA Approval History

Mavyret (glecaprevir and pibrentasvir) Tablets and Oral Pellets

Date of Approval: August 3, 2017
Company: AbbVie Inc.
Treatment for: Hepatitis C

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

• FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
• Mavyret (glecaprevir and pibrentasvir) FDA Approval History

CaroSpir (spironolactone) Oral Suspension

Date of Approval: August 4, 2017
Company: CMP Pharma, Inc.
Treatment for: Heart Failure, Edema, High Blood Pressure

CaroSpir (spironolactone) is an oral suspension formulation of the potassium-sparing diuretic spironolactone indicated for the treatment of heart failure, management of edema, and for use as an add-on therapy in the treatment of hypertension.

• CMP Pharma, Inc. Announces FDA Approval of CaroSpir (spironolactone) Oral Suspension
• CaroSpir (spironolactone) FDA Approval History

Besponsa (inotuzumab ozogamicin) for Injection

Date of Approval: August 17, 2017
Company: Pfizer Inc.
Treatment for: Acute Lymphoblastic Leukemia

Besponsa (inotuzumab ozogamicin) is a CD22 monoclonal antibody and calicheamicin cytotoxic agent conjugate indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.

• FDA Approves Besponsa (inotuzumab ozogamicin) for Relapsed or Refractory Acute Lymphoblastic Leukemia
• Besponsa (inotuzumab ozogamicin) FDA Approval History

Duzallo (allopurinol and lesinurad) Tablets

Date of Approval: August 18, 2017
Company: Ironwood Pharmaceuticals, Inc.
Treatment for: Gout

Marketing Status: Discontinued

Duzallo (allopurinol and lesinurad) is a xanthine oxidase inhibitor and URAT1 inhibitor fixed-dose combination for the treatment of hyperuricemia in patients with uncontrolled gout.

• FDA Approves Duzallo (lesinurad and allopurinol) for Hyperuricemia in Patients with Uncontrolled Gout
• Duzallo (allopurinol and lesinurad) FDA Approval History

Gocovri (amantadine hydrochloride) Extended-Release Capsules - formerly ADS-5102

Date of Approval: August 24, 2017
Company: Adamas Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease

• for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
• as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes.

• FDA Approves Gocovri (amantadine) for the Treatment of Dyskinesia in Parkinson's Disease Patients
• Gocovri (amantadine hydrochloride) FDA Approval History

KedRAB (rabies immunoglobulin human) Injection

Date of Approval: August 23, 2017
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies Prophylaxis

KedRAB [rabies immunoglobulin (human)] is a human plasma derived anti-rabies immunoglobulin indicated for post-exposure prophylaxis (PEP) of rabies infection.

• FDA Approves KedRAB [rabies immune globulin (Human)] for Post-Exposure Prophylaxis of Rabies Infection
• KedRAB (rabies immunoglobulin human) FDA Approval History

Cyltezo (adalimumab-adbm) Injection

Date of Approval: August 25, 2017
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody interchangeable biosimilar to Humira, approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira
• Cyltezo (adalimumab-adbm) FDA Approval History

(benznidazole) Tablets

Date of Approval: August 29, 2017
Company: Chemo Research, S. L.
Treatment for: Chagas Disease

Benznidazole is an antiprotozoal indicated for the treatment of Chagas disease, or American trypanosomiasis, a parasitic infection caused by Trypanosoma cruzi.

• FDA Approves Benznidazole as First U.S. Treatment for Chagas Disease
• benznidazole FDA Approval History

Vabomere (meropenem and vaborbactam) Injection - formerly Carbavance

Date of Approval: August 29, 2017
Company: The Medicines Company
Treatment for: Urinary Tract Infection

Vabomere (meropenem and vaborbactam) is a carbapenem and beta-lactamase inhibitor combination for the treatment of complicated urinary tract infections (cUTIs).

• FDA Approves Vabomere (meropenem and vaborbactam) for Complicated Urinary Tract Infections
• Vabomere (meropenem and vaborbactam) FDA Approval History

Kymriah (tisagenlecleucel) Suspension for Intravenous Infusion - formerly CTL019

Date of Approval: August 30, 2017
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Lymphoblastic Leukemia, B-Cell Lymphoma, Follicular Lymphoma

Kymriah (tisagenlecleucel) is a chimeric antigen receptor T cell (CAR-T) therapy for the treatment of B-cell acute lymphoblastic leukemia (ALL), large B-cell lymphoma, and follicular lymphoma (FL).

• FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia
• Kymriah (tisagenlecleucel) FDA Approval History

Mylotarg (gemtuzumab ozogamicin) Injection

Date of Approval: September 1, 2017
Company: Pfizer Inc.
Treatment for: Acute Myeloid Leukemia

Mylotarg (gemtuzumab ozogamicin) is a D33-directed antibody-drug conjugate indicated for:

• treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older.
• treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older.

• FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia
• Mylotarg (gemtuzumab ozogamicin) FDA Approval History

Aliqopa (copanlisib) Injection

Date of Approval: September 14, 2017
Company: Bayer Healthcare Pharmaceuticals, Inc.
Treatment for: Follicular Lymphoma

Aliqopa (copanlisib) is a phosphatidylinositol-3-kinase (PI3K) inhibitor indicated for the treatment of adult patients with relapsed follicular lymphoma (FL).

• FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma
• Aliqopa (copanlisib) FDA Approval History

Mvasi (bevacizumab-awwb) Injection

Date of Approval: September 14, 2017
Company: Amgen Inc.
Treatment for: Non Small Cell Lung Cancer, Colorectal Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Mvasi (bevacizumab-awwb) is an anti-vascular endothelial growth factor A (anti-VEGF) monoclonal antibody biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

• FDA Approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin
• Mvasi (bevacizumab-awwb) FDA Approval History

Adzenys ER (amphetamine) Extended-Release Liquid Suspension - formerly NT-0201

Date of Approval: September 15, 2017
Company: Neos Therapeutics, Inc.
Treatment for: Attention-Deficit Hyperactivity Disorder (ADHD)

Adzenys ER (amphetamine) is an extended-release liquid suspension formulation of the central nervous system (CNS) stimulant amphetamine indicated for the treatment of ADHD in patients 6 years and older.

• Neos Therapeutics Receives U.S. FDA Approval of Adzenys ER (amphetamine) Extended-Release Oral Suspension for ADHD
• Adzenys ER (amphetamine) FDA Approval History

Solosec (secnidazole) Oral Granules

Date of Approval: September 15, 2017
Company: Lupin Pharmaceuticals, Inc.
Treatment for: Bacterial Vaginosis, Trichomoniasis

Solosec (secnidazole) is a nitroimidazole antimicrobial for use as a single-dose oral therapy in the treatment of bacterial vaginosis (BV) and trichomoniasis.

• FDA Approves Symbiomix Therapeutics’ Solosec (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
• Solosec (secnidazole) FDA Approval History

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta₂-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

• FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD
• Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) FDA Approval History

Xhance (fluticasone propionate) Nasal Spray - formerly OPN-375

Date of Approval: September 18, 2017
Company: OptiNose US Inc.
Treatment for: Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps, Rhinitis

Xhance (fluticasone propionate) is a topical nasal corticosteroid indicated for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic rhinosinusitis without nasal polyps (CRSsNP) in adults.

• Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
• Xhance (fluticasone propionate) FDA Approval History

Verzenio (abemaciclib) Tablets

Date of Approval: September 28, 2017
Company: Eli Lilly and Company
Treatment for: Breast Cancer

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 used for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+ HER2-) metastatic breast cancer.

• FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
• Verzenio (abemaciclib) FDA Approval History

Fiasp (insulin aspart) Injection

Date of Approval: September 29, 2017
Company: Novo Nordisk
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Fiasp (insulin aspart) is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. Fiasp is a newer formulation of NovoLog, in which the addition of niacinamide (vitamin B3) helps to increase the speed of initial insulin absorption.

• Novo Nordisk Receives FDA Approval for Fiasp (insulin aspart injection), a New Fast-Acting Mealtime Insulin
• Fiasp (insulin aspart) FDA Approval History

Ascor (ascorbic acid) Injection

Date of Approval: October 2, 2017
Company: McGuff Pharmaceuticals, Inc.
Treatment for: Scurvy

Ascor (ascorbic acid) is an intravenous vitamin C formulation indicated for the short term treatment of scurvy.

• FDA Approves Ascor (Ascorbic Acid Injection, USP) for the Treatment of Scurvy
• Ascor (ascorbic acid) FDA Approval History

Zilretta (triamcinolone acetonide) Extended-Release Injectable Suspension

Date of Approval: October 6, 2017
Company: Flexion Therapeutics, Inc.
Treatment for: Osteoarthritis

Zilretta (triamcinolone acetonide extended-release injectable suspension) is a corticosteroid intra-articular injection indicated for the management of osteoarthritis pain of the knee.

• Flexion Therapeutics Announces FDA Approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis Knee Pain
• Zilretta (triamcinolone acetonide) FDA Approval History

Yescarta (axicabtagene ciloleucel) Suspension for Intravenous Infusion - formerly KTE-C19

Date of Approval: October 18, 2017
Company: Kite Pharma, Inc.
Treatment for: B-Cell Lymphoma, Follicular Lymphoma

Yescarta (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy (CAR T-cell therapy) used for the treatment of large B-cell lymphoma and follicular lymphoma.

• FDA Approves Yescarta (axicabtagene ciloleucel) CAR-T Cell Therapy to Treat Adults with Certain Types of Large B-Cell Lymphoma
• Yescarta (axicabtagene ciloleucel) FDA Approval History

Shingrix (zoster vaccine recombinant, adjuvanted) Injection

Date of Approval: October 20, 2017
Company: GlaxoSmithKline
Treatment for: Herpes Zoster, Prophylaxis

Shingrix (zoster vaccine recombinant, adjuvanted) is a non-live, recombinant subunit vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and older.

• Shingrix (zoster vaccine recombinant, adjuvanted) Approved in the U.S. for Prevention of Shingles
• Shingrix (zoster vaccine recombinant, adjuvanted) FDA Approval History

Calquence (acalabrutinib) Capsules and Tablets

Date of Approval: October 31, 2017
Company: AstraZeneca
Treatment for: Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia

Calquence (acalabrutinib) is a highly selective, potent, Bruton tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma.

• FDA Approves Calquence (acalabrutinib) for Adults with Mantle Cell Lymphoma
• Calquence (acalabrutinib) FDA Approval History

Vyzulta (latanoprostene bunod) Ophthalmic Solution - formerly Vesneo

Date of Approval: November 2, 2017
Company: Valeant Pharmaceuticals International, Inc.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Vyzulta (latanoprostene bunod) is a nitric oxide donating prostaglandin receptor agonist for the treatment of patients with open angle glaucoma or ocular hypertension.

• FDA Approves Vyzulta (latanoprostene bunod) Ophthalmic Solution for Open-Angle Glaucoma, Ocular Hypertension
• Vyzulta (latanoprostene bunod) FDA Approval History

Prevymis (letermovir) Tablets, Oral Pellets and Injection

Date of Approval: November 8, 2017
Company: Merck & Co., Inc.
Treatment for: CMV Prophylaxis

Prevymis (letermovir) is a CMV DNA terminase complex inhibitor used for the prophylaxis of cytomegalovirus (CMV) infection.

• FDA Approves Prevymis (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients
• Prevymis (letermovir) FDA Approval History

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) Injection

Date of Approval: November 10, 2017
Company: Dynavax Technologies Corporation
Treatment for: Hepatitis B Prevention

Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) is a vaccine for use in the immunization against infection caused by all known subtypes of hepatitis B virus.

• Dynavax Announces FDA Approval of Heplisav-B for Prevention of Hepatitis B in Adults
• Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) FDA Approval History

Cinvanti (aprepitant) Injection

Date of Approval: November 9, 2017
Company: Heron Therapeutics, Inc.
Treatment for: Nausea/Vomiting, Chemotherapy Induced

Cinvanti (aprepitant) is a polysorbate 80 free, intravenous formulation of aprepitant, a substance P/neurokinin-1 (NK₁) receptor antagonist indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV).

• FDA Approves Cinvanti (aprepitant) Injectable Emulsion for the Prevention of Acute and Delayed Chemotherapy-Induced Nausea and Vomiting (CINV)
• Cinvanti (aprepitant) FDA Approval History

Abilify MyCite (aripiprazole) Tablets with Sensor

Date of Approval: November 13, 2017
Company: Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health
Treatment for: Schizophrenia, Bipolar Disorder, Depression

Abilify MyCite (aripiprazole) is a tablet formulation of the approved atypical antipsychotic aripiprazole embedded with an ingestible Proteus® sensor that communicates with a wearable sensor patch and a medical software application to measure adherence in the treatment of adults with schizophrenia, bipolar I disorder, and major depressive disorder.

• FDA Approves Abilify MyCite (aripiprazole) Pill with Sensor to Digitally Track if Patients Have Ingested Their Medication
• Abilify MyCite (aripiprazole) FDA Approval History

Fasenra (benralizumab) Injection

Date of Approval: November 14, 2017
Company: AstraZeneca
Treatment for: Asthma, Eosinophilic Granulomatosis with Polyangiitis

Fasenra (benralizumab) is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody used for the treatment of eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.

• FDA Approves Fasenra (benralizumab) for Severe Eosinophilic Asthma
• Fasenra (benralizumab) FDA Approval History

Mepsevii (vestronidase alfa) Injection

Date of Approval: November 15, 2017
Company: Ultragenyx Pharmaceutical, Inc.
Treatment for: Mucopolysaccharidosis Type VII

Mepsevii (vestronidase alfa) is a recombinant human lysosomal beta glucuronidase indicated for the treatment of Mucopolysaccharidosis VII (MPS VII, Sly syndrome).

• FDA Approves Mepsevii (vestronidase alfa) for Mucopolysaccharidosis Type VII
• Mepsevii (vestronidase alfa) FDA Approval History

Hemlibra (emicizumab-kxwh) Injection

Date of Approval: November 16, 2017
Company: Genentech, Inc.
Treatment for: Hemophilia A with Inhibitors, Hemophilia A

Hemlibra (emicizumab-kxwh) is a bispecific factor IXa- and factor X-directed antibody indicated to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

• FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors
• Hemlibra (emicizumab-kxwh) FDA Approval History

Juluca (dolutegravir and rilpivirine) Tablets

Date of Approval: November 21, 2017
Company: ViiV Healthcare
Treatment for: HIV Infection

Juluca (dolutegravir and rilpivirine) is a single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of virologically suppressed HIV-1 infection.

• FDA Approves Juluca (dolutegravir and rilpivirine) for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection
• Juluca (dolutegravir and rilpivirine) FDA Approval History

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution

Date of Approval: November 28, 2017
Company: Ferring Pharmaceuticals Inc.
Treatment for: Bowel Preparation

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) is a stimulant laxative and osmotic laxative combination indicated for cleansing of the colon as a preparation for colonoscopy.

• FDA Approves Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) Oral Solution for Colonoscopy Prep
• Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid) FDA Approval History

Sublocade (buprenorphine) Sustained-Release Injection - formerly RBP-6000

Date of Approval: November 30, 2017
Company: Indivior PLC
Treatment for: Opioid Use Disorder

Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the treatment of opioid use disorder (OUD).

• FDA Approves Sublocade (buprenorphine) Once-Monthly Injection for Opioid Use Disorder
• Sublocade (buprenorphine) FDA Approval History

Impoyz (clobetasol propionate) Cream

Date of Approval: November 28, 2017
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Plaque Psoriasis

Impoyz (clobetasol propionate) is a high potency topical corticosteroid indicated for the treatment of moderate to severe plaque psoriasis.

• Dr. Reddy’s Announces Approval of Impoyz (clobetasol propionate) Cream for Plaque Psoriasis
• Impoyz (clobetasol propionate) FDA Approval History

Ogivri (trastuzumab-dkst) for Injection

Date of Approval: December 1, 2017
Company: Mylan GmbH
Treatment for: Breast Cancer, Gastric Cancer

Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.

• FDA Approves Ogivri (trastuzumab-dkst), a Biosimilar to Herceptin
• Ogivri (trastuzumab-dkst) FDA Approval History

Lonhala Magnair (glycopyrrolate) Inhalation Solution

Date of Approval: December 5, 2017
Company: Sunovion Pharmaceuticals Inc.
Treatment for: COPD

Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

• Sunovion Receives FDA Approval for Lonhala Magnair (glycopyrrolate) Inhalation Solution to Treat COPD
• Lonhala Magnair (glycopyrrolate) FDA Approval History

Ozempic (semaglutide) Injection

Date of Approval: December 5, 2017
Company: Novo Nordisk
Treatment for: Diabetes, Type 2, Cardiovascular Risk Reduction

Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog for the treatment type 2 diabetes, and to reduce the risk of major cardiovascular events in patients with type 2 diabetes and known heart disease.

• Novo Nordisk Receives FDA Approval of Ozempic (semaglutide) Injection For the Treatment of Adults with Type 2 Diabetes
• Ozempic (semaglutide) FDA Approval History

Admelog (insulin lispro) Injection

Date of Approval: December 11, 2017
Company: Sanofi
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Admelog (insulin lispro) is a follow-on rapid-acting human insulin analog (referenced to Humalog) for the treatment of patients with type 1 and type 2 diabetes.

• FDA Approves Admelog (insulin lispro) Rapid-Acting "Follow-On" Insulin Product to Treat Diabetes
• Admelog (insulin lispro) FDA Approval History

Sinuva (mometasone furoate) Sinus Implant

Date of Approval: December 8, 2017
Company: Intersect ENT, Inc.
Treatment for: Nasal Polyps

Sinuva (mometasone furoate) is a corticosteroid-eluting sinus implant indicated for the treatment of recurrent nasal polyp disease.

• Intersect ENT Announces FDA Approval of Sinuva (mometasone furoate) Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps
• Sinuva (mometasone furoate) FDA Approval History

Ixifi (infliximab-qbtx) Injection

Date of Approval: December 13, 2017
Company: Pfizer Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Ixifi (infliximab-qbtx) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade (infliximab) indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

• FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade
• Ixifi (infliximab-qbtx) FDA Approval History

Xepi (ozenoxacin) Cream

Date of Approval: December 11, 2017
Company: Medimetriks Pharmaceuticals, Inc.
Treatment for: Impetigo

Xepi (ozenoxacin) is a topical non-fluorinated quinolone for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

• Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream 1%, a Novel Topical Antibiotic for Impetigo
• Xepi (ozenoxacin) FDA Approval History

Eskata (hydrogen peroxide) Topical Solution

Date of Approval: December 14, 2017
Company: Aclaris Therapeutics, Inc.
Treatment for: Seborrheic Keratoses

Eskata (hydrogen peroxide) 40% (w/w) topical solution is a high-concentration hydrogen peroxide formulation for the treatment of raised seborrheic keratoses.

• Aclaris Therapeutics Receives FDA Approval for Eskata (hydrogen peroxide) Topical Solution, 40% (w/w) for the Treatment of Raised Seborrheic Keratoses
• Eskata (hydrogen peroxide) FDA Approval History

Prexxartan (valsartan) Oral Solution

Date of Approval: December 19, 2017
Company: Medicure Inc.
Treatment for: High Blood Pressure, Heart Failure, Left Ventricular Dysfunction

Marketing Status: Discontinued

Prexxartan (valsartan) is an angiotensin II receptor blocker (ARB) oral solution formulation indicated for the treatment of hypertension, heart failure, and left ventricular dysfunction following myocardial infarction.

• Medicure Announces FDA Approval Received for Prexxartan (valsartan) Oral Solution
• Prexxartan (valsartan) FDA Approval History

Rhopressa (netarsudil) Ophthalmic Solution

Date of Approval: December 18, 2017
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma

Rhopressa (netarsudil ophthalmic solution) is a Rho kinase inhibitor for the treatment of open-angle glaucoma or ocular hypertension.

• Aerie Pharmaceuticals Announces U.S. FDA Approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for Patients with Open-Angle Glaucoma or Ocular Hypertension
• Rhopressa (netarsudil) FDA Approval History

Luxturna (voretigene neparvovec) Intraocular Suspension for Subretinal Injection

Date of Approval: December 19, 2017
Company: Spark Therapeutics
Treatment for: Biallelic RPE65-Mediated Inherited Retinal Disease

Luxturna (voretigene neparvovec) is an adeno-associated viral (AAV) vector gene therapy for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease (IRD).

• FDA Approves Luxturna (voretigene neparvovec-rzyl) Gene Therapy to Treat Patients with a Rare Form of Inherited Vision Loss
• Luxturna (voretigene neparvovec) FDA Approval History

Macrilen (macimorelin) for Oral Solution

Date of Approval: December 20, 2017
Company: Aeterna Zentaris Inc.
Treatment for: Diagnosis of Adult Growth Hormone Deficiency

Macrilen (macimorelin) is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.

• Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency
• Macrilen (macimorelin) FDA Approval History

Giapreza (angiotensin II) Injection - formerly LJPC-501

Date of Approval: December 21, 2017
Company: La Jolla Pharmaceutical Company
Treatment for: Hypotension, Shock

Giapreza (angiotensin II) is a synthetic human angiotensin II vasoconstrictor indicated for the treatment of hypotension in adults with septic or other distributive shock.

• FDA Approves Giapreza (angiotensin II) to Treat Dangerously Low Blood Pressure
• Giapreza (angiotensin II) FDA Approval History

Steglatro (ertugliflozin) Tablets

Date of Approval: December 19, 2017
Company: Merck
Treatment for: Diabetes, Type 2

Steglatro (ertugliflozin) is a sodium-glucose co-transporter-2 (SGLT2) inhibitor used to help improve glycemic control in adults with type 2 diabetes.

• FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes
• Steglatro (ertugliflozin) FDA Approval History

Steglujan (ertugliflozin and sitagliptin) Tablets

Date of Approval: December 19, 2017
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2

Steglujan (ertugliflozin and sitagliptin) is a sodium glucose co-transporter 2 (SGLT2) inhibitor, and dipeptidyl peptidase-4 (DPP-4) inhibitor combination used to improve glycemic control in adults with type 2 diabetes.

• FDA Approves Steglujan (ertugliflozin and sitagliptin) for Type 2 Diabetes
• Steglujan (ertugliflozin and sitagliptin) FDA Approval History

Segluromet (ertugliflozin and metformin hydrochloride) Tablets

Date of Approval: December 19, 2017
Company: Merck & Co., Inc.
Treatment for: Diabetes, Type 2

Segluromet (ertugliflozin and metformin hydrochloride) is a sodium glucose co-transporter 2 (SGLT2) inhibitor and biguanide combination used to improve glycemic control in adults with type 2 diabetes.

• FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes
• Segluromet (ertugliflozin and metformin hydrochloride) FDA Approval History

Lumify (brimonidine tartrate) Ophthalmic Solution

Date of Approval: December 22, 2017
Company: Bausch + Lomb
Treatment for: Eye Redness

Lumify (brimonidine tartrate) is an over-the-counter (OTC) formulation of the alpha-adrenergic agonist brimonidine indicated for use in the treatment of ocular redness.

• Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness
• Lumify (brimonidine tartrate) FDA Approval History

Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) Inhalation Powder

Date of Approval: September 18, 2017
Company: GlaxoSmithKline
Treatment for: COPD, Asthma, Maintenance

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an inhaled corticosteroid, long-acting muscarinic antagonist (LAMA), and long-acting beta₂-adrenergic agonist (LABA) combination indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), and the maintenance treatment of asthma in patients aged 18 years and older.

• Once-Daily Trelegy Ellipta Gains Expanded Indication in the US for the Treatment of Patients with COPD
• Trelegy Ellipta (fluticasone furoate, umeclidinium and vilanterol) FDA Approval History