New Drug Applications Archive for 2018

January 2, 2018

• Tetraphase Pharmaceuticals Announces Submission of New Drug Application to FDA for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections (cIAI)
• Achaogen Announces FDA Acceptance of New Drug Application with Priority Review for Plazomicin for Treatment of Complicated Urinary Tract Infections and Bloodstream Infections
• Trevena Announces FDA Acceptance for Review of New Drug Application for Olinvo (oliceridine) Injection

January 4, 2018

• Acacia Pharma Announces FDA Acceptance of NDA Filing For Baremsis for the Management of Post-Operative Nausea & Vomiting
• Mallinckrodt Completes Stannsoporfin New Drug Application Filing

January 5, 2018

• Kala Pharmaceuticals Announces New Drug Application for Inveltys (KPI-121 1%) Has Been Accepted for Review by the U.S. Food and Drug Administration

January 8, 2018

• FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection
• Ionis' Inotersen NDA Accepted for Priority Review by the FDA

January 10, 2018

• Lipocine Announces Outcome of FDA Advisory Committee Meeting for Tlando, Testosterone Replacement Therapy in Adult Males with Hypogonadism

January 12, 2018

• Ortho Dermatologics Announces U.S. FDA Filing Acceptance For IDP-121 Acne Treatment In Lotion Form

January 21, 2018

• Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot

January 29, 2018

• Aradigm Receives Complete Response Letter from the FDA for Linhaliq NDA
• Theravance Biopharma and Mylan Announce FDA Acceptance of New Drug Application for Revefenacin (TD-4208) in Adults with Chronic Obstructive Pulmonary Disease

January 31, 2018

• Alkermes Submits New Drug Application To U.S. FDA For ALKS 5461 For The Adjunctive Treatment Of Major Depressive Disorder

February 1, 2018

• Alnylam Announces FDA Acceptance of New Drug Application (NDA) and Priority Review Status for Patisiran, an Investigational RNAi Therapeutic for the Treatment of Hereditary ATTR (hATTR) Amyloidosis

February 5, 2018

• Paratek Completes Submission of New Drug Applications to U.S. FDA for Oral and Intravenous Omadacycline for Pneumonia and Skin Infections
• Nymox Announces US NDA for Fexapotide for BPH

February 7, 2018

• SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox
• Verastem Submits NDA to FDA for Duvelisib for the Treatment of Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Follicular Lymphoma

February 8, 2018

• 60° Pharmaceuticals (60P) Receives Priority Review Designation For Malaria Drug

February 9, 2018

• Salix Provides Update on FDA Submission for Plenvu

February 12, 2018

• U.S. FDA Files New Drug Application Under Priority Review for Migalastat for Treatment of Fabry Disease
• Catalyst Pharmaceuticals Announces Plans to Resubmit New Drug Application for Firdapse
• U.S., EU and Japan Health Authorities Accept Regulatory Submissions For Review Of Pfizer’s Third-generation ALK Inhibitor Lorlatinib

February 13, 2018

• Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain

February 14, 2018

• Ortho Dermatologics Announces U.S. FDA Filing Acceptance for Jemdel Plaque Psoriasis Treatment

February 15, 2018

• FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation

February 16, 2018

• Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros

February 20, 2018

• PTC Therapeutics Receives Formal Dispute Resolution Request Decision from the FDA's Office of New Drugs
• Acorda Announces FDA Acceptance of New Drug Application for Inbrija (levodopa inhalation powder)

February 21, 2018

• Evofem Biosciences Receives Fast Track Designation for Amphora for Prevention of Chlamydia

February 23, 2018

• Mallinckrodt Receives FDA Acceptance of Stannsoporfin New Drug Application Filing
• FDA Accepts Shire’s Biologics License Application (BLA) and Grants Priority Review for Lanadelumab for the Prevention of Attacks in Hereditary Angioedema (HAE) Patients

February 27, 2018

• Tetraphase Pharmaceuticals Announces FDA Acceptance for Filing of its NDA Submission for Eravacycline for the Treatment of Complicated Intra-Abdominal Infections
• Shionogi Announces FDA New Drug Application (NDA) and EMA Marketing Authorization Application (MAA) Acceptances for Lusutrombopag (S-888711)

February 28, 2018

• Allergan Announces FDA Has Extended The Ulipristal Acetate NDA Review Period To August 2018
• U.S. FDA Accepts Shire's Biologics License Application for Calaspargase Pegol (Cal-PEG) for Acute Lymphoblastic Leukemia (ALL)

March 1, 2018

• FDA Accepts Remoxy NDA For Review

March 2, 2018

• Jazz Pharmaceuticals Announces FDA Acceptance of NDA for Solriamfetol (JZP-110) for Excessive Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

March 5, 2018

• U.S. FDA Accepts New Drug Application for Prucalopride (SHP555) for Chronic Idiopathic Constipation
• FDA Approves PDUFA Fee Waiver for Gimoti New Drug Application

March 8, 2018

• AcelRx Announces Receipt of Type A FDA Meeting Minutes and Plans to Resubmit the DSUVIA New Drug Application in Q2 2018
• TherapeuticsMD Announces FDA Acceptance of New Drug Application (NDA) and Prescription Drug User Fee Act (PDUFA) Date for TX-001HR

March 12, 2018

• Sarepta Therapeutics Announces Plan to Submit a New Drug Application (NDA) for Accelerated Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy (DMD) Amenable to Skipping Exon 53

March 22, 2018

• Progenics Pharmaceuticals Announces Three-Month Extension of PDUFA Date for Azedra (iobenguane I 131)

March 26, 2018

• Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
• Loxo Oncology Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Larotrectinib for the Treatment of TRK Fusion Cancer
• Lexicon Pharmaceuticals Announces Regulatory Submissions for Sotagliflozin to Treat Adults with Type 1 Diabetes

March 27, 2018

• FDA Advisory Committee Votes in Favor of Lucemyra (lofexidine) for the Mitigation of Opioid Withdrawal Symptoms

March 29, 2018

• Catalyst Pharmaceuticals Announces Submission of New Drug Application for Firdapse for Treatment of Lambert-Eaton Myasthenic Syndrome

April 2, 2018

• Alkermes Receives Refusal to File Letter From FDA for ALKS 5461

April 3, 2018

• US FDA Accepts Biologics License Application for Moxetumomab Pasudotox in Hairy Cell Leukemia

April 4, 2018

• U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations
• Paratek’s New Drug Applications for Oral and Intravenous Omadacycline Accepted for Priority Review by FDA

April 5, 2018

• Antares Pharma Provides Xyosted Regulatory Update

April 9, 2018

• FDA Accepts New Drug Application for Duvelisib and Grants Priority Review

April 10, 2018

• AbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

April 16, 2018

• Alkermes Announces FDA Acceptance for Review of New Drug Application for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
• FDA Grants Breakthrough Therapy Designation For Genentech’s Hemlibra (emicizumab-kxwh) in Hemophilia A Without Inhibitors

April 19, 2018

• Unanimous Positive Result of FDA Advisory Committee Meeting for First Plant-Based Pharmaceutical Cannabidiol Treatment for Seizures in Patients with Two Rare, Severe Forms of Epilepsy

April 23, 2018

• Pfizer Granted FDA Breakthrough Therapy Designation for Trumenba (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years
• Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
• FDA Advisory Committee Recommends the Approval of Baricitinib 2mg, but not 4mg, for the Treatment of Moderately-to-Severely Active Rheumatoid Arthritis
• Astellas Submits New Drug Applications for Approval of Gilteritinib for the Treatment of FLT3mut+ Relapsed or Refractory Acute Myeloid Leukemia

April 25, 2018

• AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

April 30, 2018

• FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma

May 1, 2018

• SIGA Technologies Announces Favorable Outcome of Advisory Committee In Support of TPOXX

May 2, 2018

• Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections

May 3, 2018

• Mallinckrodt Reports on FDA Joint Advisory Committee Meeting for Stannsoporfin for the Treatment of Newborns at Risk of Developing Severe Jaundice

May 9, 2018

• Lipocine Receives Complete Response Letter for Tlando From U.S. Food and Drug Administration
• AcelRx Resubmits New Drug Application for DSUVIA

May 10, 2018

• FDA Advisory Committee Votes in Favor of Waylivra (volanesorsen) for Treatment of Familial Chylomicronemia Syndrome

May 15, 2018

• Aerie Pharmaceuticals Submits NDA to FDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%

May 18, 2018

• Agile Therapeutics, Inc. Provides Regulatory Update on Twirla (AG200-15) for the Prevention of Pregnancy

May 21, 2018

• Glenmark Pharmaceuticals Announces the Company's First NDA for Ryaltris for Patients with Seasonal Allergic Rhinitis

May 22, 2018

• FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes
• INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray

May 23, 2018

• Teva Confirms September PDUFA Date for Fremanezumab

May 24, 2018

• AcelRx Announces FDA Acceptance of NDA for DSUVIA

May 28, 2018

• Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder

May 29, 2018

• U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
• Catalyst Pharmaceuticals Announces FDA Acceptance of NDA and Priority Review Status for Firdapse (amifampridine phosphate) for Lambert-Eaton Myasthenic Syndrome
• FDA Accepts Larotrectinib New Drug Application and Grants Priority Review

May 30, 2018

• Kyowa Hakko Kirin Announces FDA Notification of PDUFA Action Date Extension for Mogamulizumab
• Sage Therapeutics Announces FDA Acceptance of NDA Filing and Grant of Priority Review for Brexanolone IV in the Treatment of Postpartum Depression
• Sedor Pharmaceuticals Files NDA for CE-Fosphenytoin for Status Epilepticus

May 31, 2018

• Nektar Therapeutics Announces Submission of a New Drug Application to the U.S. FDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy

June 1, 2018

• Circassia Announces Submission of Duaklir (aclidinium and formoterol) New Drug Application

June 4, 2018

• Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA
• Evoke Announces FDA Submission of New Drug Application for Gimoti

June 6, 2018

• Intra-Cellular Therapies Initiates Rolling Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia

June 7, 2018

• U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation

June 12, 2018

• Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

June 14, 2018

• Motif Bio Submits NDA for Iclaprim

June 18, 2018

• FDA Issues Complete Response Letter for Duobrii (halobetasol propionate and tazarotene) Lotion

June 19, 2018

• Alexion Submits Application for Priority Review and Approval of ALXN1210 as a Treatment for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) in the U.S.

June 25, 2018

• Historic New Drug Application for the use of Scenesse (afamelanotide) in Rare Metabolic Disorder Erythropoietic Protoporphyria (EPP)
• Clinuvel Completes Scenesse FDA Filing

June 26, 2018

• Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER

June 27, 2018

• FDA Grants Priority Review for Pfizer’s New Drug Application for Glasdegib in Patients with Previously Untreated Acute Myeloid Leukemia

June 29, 2018

• Ocular Therapeutix Announces NDA Resubmission of Dextenza

July 12, 2018

• FDA Advisory Committee Endorses the Effectiveness and Safety of Single-Dose Tafenoquine for the Radical Cure of P. vivax Malaria
• Amgen And UCB Resubmit Biologics License Application (BLA) For Evenity (romosozumab) To The US FDA

July 16, 2018

• Camurus Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder

July 18, 2018

• Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma

July 27, 2018

• INSYS Therapeutics Receives Complete Response Letter from FDA for Buprenorphine NDA

July 30, 2018

• Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
• FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis

August 6, 2018

• Complete Response Letter Issued for Remoxy

August 8, 2018

• FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline

August 13, 2018

• FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters

August 14, 2018

• Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections

August 15, 2018

• Ortho Dermatologics Resubmits U.S. New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion

August 16, 2018

• Evoke Pharma’s Gimoti NDA Accepted for FDA Review

August 21, 2018

• Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application

August 22, 2018

• Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter

August 27, 2018

• Akcea and Ionis Receive Complete Response Letter for Waylivra from FDA

August 29, 2018

• Evolus Receives Acceptance of FDA BLA Resubmission for DWP-450

August 31, 2018

• FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD

September 4, 2018

• Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression

September 13, 2018

• Acorda Announces FDA Extends Inbrija NDA Review Period
• Ardelyx Submits New Drug Application for Tenapanor for IBS-C

September 18, 2018

• Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer

September 25, 2018

• Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients

September 28, 2018

• Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia

October 1, 2018

• Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency

October 5, 2018

• U.S. FDA Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review

October 8, 2018

• FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
• Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS)

October 9, 2018

• Bausch Health's Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults

October 11, 2018

• Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome

October 12, 2018

• FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain

October 16, 2018

• Kala Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for KPI-121 0.25% for Dry Eye Disease

October 18, 2018

• FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation
• ViiV Healthcare Submits New Drug Application to FDA for Single-Tablet, Two-Drug Regimen of Dolutegravir and Lamivudine for Treatment of HIV

October 22, 2018

• DBV Technologies Announces Submission of Biologics License Application for Viaskin Peanut to the U.S. Food and Drug Administration

October 23, 2018

• Xeris Pharmaceuticals Announces FDA Acceptance for Review of NDA for Its Ready-to-Use Glucagon Rescue Pen

October 29, 2018

• Acer Therapeutics Submits NDA for Edsivo (celiprolol) for the Treatment of Vascular Ehlers-Danlos syndrome (vEDS)

October 30, 2018

• FDA Grants Priority Review for Sanofi's Dengue Vaccine Candidate

October 31, 2018

• Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management

November 1, 2018

• Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
• Nabriva Therapeutics Completes Submission of New Drug Application to U.S. Food and Drug Administration for Intravenous Contepo to Treat Complicated Urinary Tract Infections

November 2, 2018

• Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
• Trevena Receives Complete Response Letter for Oliceridine from FDA

November 6, 2018

• Acacia Pharma Resubmits Barhemsys New Drug Application

November 7, 2018

• Karyopharm’s Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

November 13, 2018

• Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration
• Ardelyx Announces FDA Acceptance of the Filing of its New Drug Application for Tenapanor for the Treatment of Patients with IBS-C

November 14, 2018

• Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine

November 15, 2018

• Glenmark Pharmaceuticals Announces New Data Presentations on Ryaltris at the ACAAI Annual Scientific Meeting 2018

November 19, 2018

• Evolus Receives Conditional FDA Acceptance of Jeuveau Brand Name

November 20, 2018

• Sage Therapeutics Receives Notification of PDUFA Extension for Zulresso (brexanolone) Injection

November 21, 2018

• FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for FLT3 Inhibitor Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML

November 29, 2018

• FDA Accepts Filing of New Estrogen-free Oral Contraceptive Slinda (drospirenone) Developed by Exeltis

December 3, 2018

• Shield Therapeutics Announces the NDA for Feraccru has been Accepted for Filing and Review by FDA
• Novartis Announces FDA Filing Acceptance and Priority Review of AVXS-101, a One-Time Treatment Designed to Address the Genetic Root Cause of SMA Type 1

December 7, 2018

• New Barhemsys PDUFA Date Confirmed for 5 May 2019

December 10, 2018

• Pfenex Submits New Drug Application to U.S. FDA Seeking Approval of PF708 for the Treatment of Osteoporosis

December 11, 2018

• Intra-Cellular Therapies Announces FDA Acceptance of New Drug Application for Lumateperone for the Treatment of Schizophrenia

December 17, 2018

• Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration
• UroGen Pharma Initiates Rolling Submission of New Drug Application (NDA) for UGN-101 for the Treatment of Low-Grade Upper Tract Urothelial Cancer
• Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis
• Notification of a New Drug Application for HP-3070 (Transdermal Patch for the Treatment of Schizophrenia) in the U.S.

December 19, 2018

• Clearside Biomedical Submits New Drug Application for Xipere for the Treatment of Macular Edema Associated with Uveitis
• DBV Technologies Provides Update on Viaskin Peanut for Children Four to 11 Years of Age - BLA Withdrawn

December 20, 2018

• Assertio Therapeutics Announces Submission of NDA for FDA Approval of Cosyntropin Depot
• Sarepta Therapeutics Completes Submission of New Drug Application Seeking Approval of Golodirsen (SRP-4053) in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53
• Nabriva Therapeutics Submits New Drug Applications to U.S. Food and Drug Administration for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
• AbbVie Submits New Drug Application to U.S. FDA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis
• Fennec Pharmaceuticals Initiates Rolling New Drug Application to FDA for Pedmark
• Pharmaxis Announces Resubmission of Bronchitol NDA

December 21, 2018

• Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
• Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4–17
• Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea

December 23, 2018

• Braeburn Announces Tentative FDA Approval of Brixadi (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder

December 26, 2018

• Kala Pharmaceuticals Announces New Drug Application for KPI-121 0.25% for Dry Eye Disease Has Been Accepted for Review by the U.S. Food and Drug Administration

December 27, 2018

• Spectrum Pharmaceuticals Announces Submission of Biologics License Application to the FDA for Rolontis (eflapegrastim) as a Treatment for Chemotherapy-Induced Neutropenia

December 31, 2018

• FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management