New Indications and Dosage Forms for 2017
See also: New Drug Approvals for 2017
January 5, 2017
January 19, 2017
January 25, 2017
January 26, 2017
- Symbicort Approved for the Treatment of Asthma in Patients 6 to 12 Years of Age
- U.S. FDA Approves 72 mcg Dose of Linzess (linaclotide) for Adults with Chronic Idiopathic Constipation
January 28, 2017
February 1, 2017
February 2, 2017
February 16, 2017
February 22, 2017
March 15, 2017
March 20, 2017
March 30, 2017
- FDA Approves Expanded Indication for Qudexy XR (topiramate) Extended-Release Capsules to Include Prophylaxis of Migraine Headache in Adults and Adolescents
- FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's Humira (adalimumab) Prescribing Information
March 31, 2017
- Tagrisso (osimertinib) Receives FDA Full Approval
- Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer
April 7, 2017
- FDA Approves Harvoni (ledipasvir and sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older
- FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older
April 17, 2017
- FDA Grants Genentech’s Tecentriq (atezolizumab) Accelerated Approval as Initial Treatment for Certain People with Advanced Bladder Cancer
- FDA Approves Genentech’s Lucentis (ranibizumab) for all Forms of Diabetic Retinopathy
April 25, 2017
April 27, 2017
May 1, 2017
May 9, 2017
May 10, 2017
May 17, 2017
May 18, 2017
May 22, 2017
May 23, 2017
May 26, 2017
May 30, 2017
June 6, 2017
June 16, 2017
- Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults
- FDA Approves Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma
June 22, 2017
June 29, 2017
July 6, 2017
July 11, 2017
July 21, 2017
July 24, 2017
July 27, 2017
July 28, 2017
August 1, 2017
- Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment
- FDA Approves Kalydeco (ivacaftor) for People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
- FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV
August 2, 2017
August 6, 2017
August 17, 2017
August 25, 2017
August 28, 2017
August 30, 2017
August 31, 2017
September 5, 2017
September 6, 2017
September 14, 2017
- Sunovion’s Aptiom (eslicarbazepine acetate) Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents 4 Years of Age and Older
- CSL Behring Announces FDA Approval of Privigen [Immune Globulin Intravenous (Human), 10% Liquid] for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Adults
September 15, 2017
September 18, 2017
September 21, 2017
September 22, 2017
- Bristol-Myers Squibb’s Opdivo (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib
- FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1
October 3, 2017
October 12, 2017
October 13, 2017
October 20, 2017
October 23, 2017
- FDA Approves Once-Weekly Bydureon BCise (exenatide) for Patients with Type-2 Diabetes
- FDA Approves Soliris (eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (gMG)
October 25, 2017
October 30, 2017
November 6, 2017
- FDA Approves Alecensa (alectinib) as First-Line Treatment for ALK-Positive Metastatic Non-Small Cell Lung Cancer
- FDA Approves Zelboraf (vemurafenib) for Erdheim-Chester Disease with BRAF V600 Mutation
November 7, 2017
November 9, 2017
November 10, 2017
November 13, 2017
November 15, 2017
- Faslodex (fulvestrant) Receives FDA Approval for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib
- Noden Pharma Announces FDA Approval of Tekturna (aliskiren) Oral Pellets for the Treatment of Hypertension in Adults and Children 6 Years of Age and Older
November 16, 2017
- FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma
- FDA Approves Sutent (sunitinib malate) for Adjuvant Treatment of Adult Patients at High Risk of Recurrent Renal Cell Carcinoma
November 20, 2017
November 29, 2017
December 1, 2017
- FDA Approves Amgen's Repatha (evolocumab) to Prevent Heart Attack and Stroke
- Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis
December 5, 2017
December 12, 2017
- Omeros Corporation Announces FDA Approval of Omidria for Use in Pediatric Patients
- FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
December 14, 2017
December 19, 2017
- Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma
- FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)
December 20, 2017
- Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease
- FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer