New Indications and Dosage Forms for 2015

January 5, 2015

• FDA Approves Gadavist (gadobutrol) as the First MRI Contrast Agent for Patients Less Than 2 Years

January 6, 2015

• Bellafill Receives FDA Approval for the Treatment of Acne Scars

January 29, 2015

• FDA Expands Approved Use of Imbruvica (ibrutinib) for Waldenström’s Macroglobulinemia

January 30, 2015

• FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder
• Zogenix Receives FDA Approval for New Abuse-Deterrent Formulation of Zohydro ER

February 6, 2015

• FDA Approves Lucentis (ranibizumab) to Treat Diabetic Retinopathy in People with Diabetic Macular Edema

February 16, 2015

• Eisai Receives Approval for Antiepileptic Drug Banzel (rufinamide) As Adjunctive Treatment For Pediatric Patients

February 18, 2015

• FDA Expands Indication for Revlimid (lenalidomide) in Combination with Dexamethasone to Include Patients Newly Diagnosed with Multiple Myeloma

March 4, 2015

• FDA Expands Approved use of Opdivo (nivolumab) to Treat Lung Cancer

March 13, 2015

• Actavis Receives FDA Approval of Saphris for Pediatric Patients with Bipolar I Disorder

March 16, 2015

• Actavis Receives FDA Approval for Viibryd (vilazodone HCl) 20mg Once Daily as a Therapeutic Dose

March 18, 2015

• FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations

March 25, 2015

• FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular Edema

March 30, 2015

• FDA Approves New Crushing Option for the Administration of Brilinta

April 20, 2015

• FDA Approves New Formulation of Minocin (minocycline) for Injection

April 23, 2015

• Medicure Announces Approval of Expanded Dosing Time For Aggrastat

April 24, 2015

• FDA Approves Cyramza (Ramucirumab) for Use with FOLFIRI in Second-Line Treatment of Metastatic Colorectal Cancer

April 30, 2015

• FDA Approves Breo Ellipta (fluticasone furoate/vilanterol) for Asthma

May 8, 2015

• FDA Approves Avelox (moxifloxacin) as Additional Antibacterial Treatment for Plague

May 15, 2015

• FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients

May 27, 2015

• FDA Approves Xifaxan (rifaximin) for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea)

May 28, 2015

• FDA Approves Rapamune (sirolimus) for Rare Lung Disease Lymphangioleiomyomatosis

June 1, 2015

• FDA Approves Expanded Indication for Qudexy XR (Topiramate) for Pediatric Patients

June 12, 2015

• FDA Approves Promacta for New Pediatric Chronic Immune Thrombocytopenia (cITP) Indication

June 16, 2015

• FDA Approves Zomig (zolmitriptan) Nasal Spray for Migraine in Pediatric Patients (Ages 12-17)

June 22, 2015

• FDA Approves Fycompa as Adjunctive Treatment for Primary Generalized Tonic-Clonic Seizures

July 13, 2015

• FDA Approves Iressa (gefitinib) for First-Line Treatment of Metastatic Non-Small Cell Lung Cancer

July 17, 2015

• Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity

July 24, 2015

• FDA Approves Kyprolis (carfilzomib) for Combination Treatment of Patients with Relapsed Multiple Myeloma

July 31, 2015

• FDA Approves Finacea (azelaic acid) Foam for Rosacea

August 11, 2015

• FDA Approves Zubsolv for Induction of Buprenorphine Maintenance Therapy in Patients Suffering from Opioid Dependence

August 13, 2015

• FDA Approves Wilate License Supplement - Perioperative Management of Bleeding in Patients with von Willebrand Disease
• BioDelivery Sciences Announces FDA Approval of New Formulation of Onsolis (fentanyl buccal soluble film) CII

August 14, 2015

• FDA Approves Oxycontin (oxycodone) for Children as Young as 11

August 17, 2015

• FDA Approves Expanded Label for Procysbi to Treat Children Aged 2-6 Years With Nephropathic Cystinosis

August 24, 2015

• FDA Extends Use of Promacta (eltrombopag) in Pediatric Patients with Immune Thrombocytopenic Purpura

August 28, 2015

• FDA Approves New Indication for Aptiom (eslicarbazepine acetate) as Monotherapy for Partial-Onset Seizures

September 2, 2015

• FDA Approves Pediatric Indication for Emend (aprepitant) Capsules in Combination with Other Antiemetic Agents

September 3, 2015

• FDA Approves Expanded Indication for Brilinta to Include Long-Term Use in Patients with a History of Heart Attack

September 11, 2015

• FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa

September 16, 2015

• FDA Approves Spiriva Respimat (tiotropium) for Maintenance Treatment of Asthma in Adults and Adolescents

September 25, 2015

• FDA Approves Betaconnect Electronic Autoinjector for the Treatment of Relapsing-Remitting Multiple Sclerosis

October 1, 2015

• BMS Receives FDA Approval for Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Melanoma
• FDA Approves Juvéderm Ultra XC for Lip Augmentation

October 2, 2015

• FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer
• FDA Approves New Treatment Combination of Gilead’s Letairis with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1)

October 9, 2015

• FDA Expands Approved Use of Opdivo (nivolumab) in Advanced Lung Cancer

October 28, 2015

• FDA Approves Yervoy to Reduce the Risk of Melanoma Returning after Surgery

November 12, 2015

• FDA Approves New Indications for Harvoni to Include Patients with Genotypes 4, 5 and 6 HCV and Patients Co-Infected with HIV

November 23, 2015

• FDA Approves Pradaxa for Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism after Hip Replacement Surgery
• FDA Approves BioThrax for Use After Known or Suspected Anthrax Exposure
• FDA Approves Opdivo to Treat Metastatic Renal Cell Carcinoma

December 15, 2015

• FDA Approves Expanded Age Indication for Gardasil 9 in Males

December 18, 2015

• FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma

December 23, 2015

• Merz North America Announces FDA Approval of Xeomin (incobotulinumtoxinA) for Treatment of Adult Upper Limb Spasticity