New Indications and Dosage Forms for 2016
See also: New Drug Approvals for 2016
January 14, 2016
January 15, 2016
January 19, 2016
January 21, 2016
- Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for Dalvance (dalbavancin)
- U.S. Food And Drug Administration Approves Humulin R U-500 KwikPen
- FDA Approves Kyprolis (carfilzomib) Combination Therapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
January 22, 2016
January 23, 2016
January 27, 2016
January 28, 2016
February 5, 2016
February 16, 2016
February 19, 2016
February 25, 2016
February 26, 2016
- FDA Approves Genentech’s Gazyva (obinutuzumab) for Certain People with Previously Treated Follicular Lymphoma
- FDA Approves Afinitor (everolimus) for Progressive, Nonfunctional Gastrointestinal and Lung Neuroendocrine Tumors (NET)
March 4, 2016
March 11, 2016
April 15, 2016
April 29, 2016
- FDA Approves Bayer's Gadavist (gadobutrol) Injection for use with Magnetic Resonance Angiography of Supra-Aortic Arteries
- Teva Announces FDA Approval of ProAir RespiClick (albuterol sulfate) Inhalation Powder for Pediatric Asthma Patients Ages 4 to 11
May 2, 2016
- Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in U.S. to Avoid Name Confusion
- Eisai Announces FDA Approval of Fycompa (perampanel) Oral Suspension
May 9, 2016
- Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin)
- U.S. FDA Expands Imbruvica (ibrutinib) Label to Include Overall Survival Data in Previously Untreated Chronic Lymphocytic Leukemia (CLL) and New Indication for Small Lymphocytic Lymphoma (SLL) Patients
May 13, 2016
May 17, 2016
May 24, 2016
May 31, 2016
- Allergan Receives FDA Approval of Teflaro (ceftaroline fosamil) for Pediatric Patients
- FDA Approves Once-Daily Jentadueto XR (linagliptin and metformin hydrochloride extended-release) for Type 2 Diabetes
June 1, 2016
June 23, 2016
June 30, 2016
July 7, 2016
July 8, 2016
July 11, 2016
July 12, 2016
July 18, 2016
July 19, 2016
- FDA Expands Indication For Type 2 Diabetes Treatment Synjardy (Empagliflozin/Metformin Hydrochloride) To Include Treatment-Naïve Adults
- Eisai Inc. and Arena Pharmaceuticals Announce FDA Approval of Belviq XR (lorcaserin HCl) Extended-Release Tablets
- Valeant and Progenics Announce FDA Approves Relistor Tablets for the Treatment of Opioid-Induced Constipation in Adults with Chronic Non-Cancer Pain
August 1, 2016
August 5, 2016
August 31, 2016
September 1, 2016
September 21, 2016
September 23, 2016
- FDA Approves Expanded Indications for Ilaris (canakinumab) for Three Rare Periodic Fever Syndromes
- U.S. FDA Approves Labeling Update of Rexulti (brexpiprazole) for Maintenance Treatment of Schizophrenia
September 26, 2016
September 28, 2016
October 11, 2016
October 14, 2016
October 18, 2016
October 19, 2016
October 24, 2016
November 4, 2016
- FDA Approves Expanded Use of Enbrel (etanercept) to Treat Children with Chronic Moderate-To-Severe Plaque Psoriasis
- ViiV Healthcare Announces FDA Approval of Selzentry (maraviroc) for Use in Children and Adolescents Living With HIV
November 10, 2016
November 18, 2016
November 21, 2016
November 27, 2016
December 2, 2016
- FDA Approves Jardiance (empagliflozin) to Reduce Cardiovascular Death in Adults with Type 2 Diabetes