New Indications and Dosage Forms for 2014

January 9, 2014

• GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib)

January 29, 2014

• Teva Announces U.S. FDA Approval of Three-Times-a-Week Copaxone (glatiramer acetate injection) 40mg/mL

January 31, 2014

• Valeant Pharmaceuticals Announces Approval of Retin-A Micro Microsphere 0.08%

February 12, 2014

• FDA Approves Imbruvica (ibrutinib) to Treat Chronic Lymphocytic Leukemia

March 3, 2014

• FDA Approves Bydureon Pen for Once-Weekly Treatment of Adults with Type 2 Diabetes

March 14, 2014

• FDA Approves Merck’s Noxafil (posaconazole) Injection

March 18, 2014

• FDA Approves Eliquis to Reduce Risk of Blood Clots Following Hip Or Knee Replacement Surgery

March 21, 2014

• FDA Approves Xolair (omalizumab) for Chronic Idiopathic Urticaria

March 28, 2014

• FDA Approves Topamax for Migraine Prevention in Adolescents

March 31, 2014

• Pfizer Statement on U.S. FDA Approval of Over-the-Counter Nexium 24HR

April 7, 2014

• FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older
• FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism

May 23, 2014

• FDA Approves First-Line Use of Vectibix (panitumumab) Plus FOLFOX for Patients with Wild-Type KRAS Metastatic Colorectal Cancer

June 13, 2014

• FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body

July 17, 2014

• Octapharma USA Announces FDA Approval of Octagam 10% for the treatment of Chronic Immune Thrombocytopenic Purpura (ITP)

July 28, 2014

• FDA Expands Approved Use of Imbruvica (ibrutinib) for Chronic Lymphocytic Leukemia

July 29, 2014

• Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema

August 1, 2014

• FDA Expands Approval of Lumizyme to treat Pompe Disease Patients of All Ages

August 14, 2014

• FDA Approves Avastin for Metastatic Cervical Cancer

August 21, 2014

• FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

August 25, 2014

• Iroko Pharmaceuticals Gains FDA Approval of Zorvolex for Management of Osteoarthritis Pain

August 26, 2014

• FDA Approves New Indication for Promacta (eltrombopag) for Severe Aplastic Anemia

September 23, 2014

• FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis

September 24, 2014

• Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle

September 25, 2014

• FDA Approves Spiriva Respimat (tiotropium) for the Maintenance Treatment of COPD
• FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease

September 29, 2014

• FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) for Schizophrenia
• FDA Approves Revised Indication for Ozurdex for the Treatment of Diabetic Macular Edema

October 8, 2014

• FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

October 17, 2014

• FDA Approves Labeling with Abuse-Deterrent Features for Embeda (morphine/naltrexone)

October 29, 2014

• Flublok Influenza Vaccine Now Approved for Adults Ages 18 and Older

November 5, 2014

• FDA Approves Cyramza (ramucirumab) in Combination with Paclitaxel for Advanced Gastric Cancer after Prior Chemotherapy
• FDA Approves Olysio (simeprevir) in Combination with Sofosbuvir for Genotype 1 Chronic Hepatitis C Infection

November 13, 2014

• FDA Approves sNDA for Invega Sustenna (paliperidone palmitate) for Schizoaffective Disorder

November 14, 2014

• FDA Approves Avastin (bevacizumab) Plus Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer

November 17, 2014

• Keryx Biopharmaceuticals Announces Trade Name Auryxia for Ferric Citrate

December 1, 2014

• Bellafill to Replace ArteFill as New Brand

December 2, 2014

• Sanofi Receives FDA Approval of Priftin (rifapentine) for Latent Tuberculosis Infection

December 4, 2014

• FDA Approves Jakafi (ruxolitinib) for Polycythemia Vera

December 6, 2014

• FDA Approves Labeling Update Of Abilify Maintena for Acutely Relapsed Adults With Schizophrenia

December 8, 2014

• FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy

December 12, 2014

• FDA Expands Approved use of Cyramza to Treat Aggressive Non-Small Cell Lung Cancer
• FDA Approves Two Higher Dosage Strengths of Zubsolv
• Sanofi Pasteur Announces FDA Approval Of Fluzone Intradermal Quadrivalent

December 16, 2014

• FDA Approves Somatuline Depot (lanreotide) for Gastroenteropancreatic Neuroendocrine Tumors

December 19, 2014

• Teva Announces FDA Approval of QNASL for Children with Seasonal and Perennial Allergic Rhinitis
• Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze

December 23, 2014

• FDA Approves Teva’s Granix (tbo-filgrastim) Injection for Self-Administration

December 29, 2014

• FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation