New Indications and Dosage Forms for 2010

January 5, 2010

• FDA Approves Addition of Sustained Overall Survival Benefit to Label for Velcade (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma

January 11, 2010

• HIV/AIDS Update - Atripla label update reflects new efficacy, safety and resistance data in treatment experienced patients

January 28, 2010

• U.S. Food and Drug Administration Approves Labeling Update for Prezista To Include 96-Week Data in HIV-1 Infected Adult Patients

February 1, 2010

• GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer

February 5, 2010

• FDA Approves Once-A-Day Lamictal XR as Add-On Epilepsy Therapy for Primary Generalized Tonic-Clonic Seizures

February 9, 2010

• FDA Approves Crestor to Reduce Stroke, Heart Attack Risk

February 11, 2010

• FDA Approves Benicar for the Treatment of High Blood Pressure in Children and Adolescents aged 6-16

February 12, 2010

• Abbott Receives U.S. FDA Approval for Heat-Stable Norvir (ritonavir) Tablets

February 19, 2010

• FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia

February 22, 2010

• FDA Approves Once-Daily Mirapex ER for the Treatment of Early Parkinson's Disease

March 3, 2010

• Novo Nordisk Receives FDA Approval for Norditropin FlexPro for Growth Hormone Treatment

March 4, 2010

• Kapidex (dexlansoprazole) Renamed Dexilant in U.S. to Avoid Name Confusion

March 10, 2010

• Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults

March 12, 2010

• FDA Approves Watson's Trelstar 22.5 mg, the First and Only 6-Month Intramuscular GnRH Agonist for the Palliative Treatment of Advanced Prostate Cancer
• FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS)

March 22, 2010

• Galderma Received FDA Approval of Differin (adapalene) Lotion, 0.1%, the First Retinoid Available in Lotion Formulation

March 24, 2010

• Once-Daily Mirapex ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease

March 25, 2010

• FDA Approves New Use of Xifaxan for Patients with Liver Disease

April 6, 2010

• FDA Approves New Formulation for OxyContin

April 18, 2010

• FDA Approves Tarceva as a Maintenance Therapy for Advanced Non-Small Cell Lung Cancer

April 19, 2010

• CSL Behring Receives FDA Approval to Extend Shelf Life for Privigen from 24 to 36 Months

April 28, 2010

• Abbott Receives FDA Approval for Once-Daily Dosing of Kaletra (lopinavir / ritonavir) for Treatment-Experienced Patients

May 3, 2010

• Abbott Receives FDA Approval for Creon to Include Dosing Information for Patients With Chronic Pancreatitis and Pancreatectomy

June 18, 2010

• Novartis International AG (CH) - FDA approves Tasigna for newly diagnosed chronic myeloid leukemia patients, data demonstrate major advance over Glivec

June 22, 2010

• Forest and Merz Announce FDA Approval of Namenda XR for the Treatment of Moderate to Severe Dementia of the Alzheimer's Type

June 23, 2010

• FDA Approves Lucentis (ranibizumab) for the Treatment of Macular Edema Following Retinal Vein Occlusion

July 6, 2010

• Three Rivers Pharmaceuticals Announces FDA Approval Of Expanded Labeling of Infergen

July 7, 2010

• FDA Approves Daytrana (methylphenidate transdermal system) CII for the Treatment of ADHD in Adolescents

July 26, 2010

• Eisai Inc. and Pfizer Inc Announce U.S. FDA Approval for New Higher-Dose Aricept (donepezil HCl) 23 mg Tablet for the Treatment of Moderate-to-Severe Alzheimer's Disease

July 29, 2010

• Abbott's Simcor (niacin extended-release/simvastatin) Receives FDA Approval for New Dosage Strengths

August 5, 2010

• FDA Approves New Taxotere (docetaxel) Injection Concentrate Formulation

August 10, 2010

• FDA Approves Longer Use of Valcyte for Adult Kidney Transplant Patients at High Risk of Developing Cytomegalovirus (CMV) Disease

August 31, 2010

• Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Approval for Suboxone (buprenorphine and naloxone) Sublingual Film C-III

September 1, 2010

• Allergan, Inc. Receives FDA Approval for Lumigan 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients

September 7, 2010

• Merck Receives Approval from FDA for Expanded Indications for Atypical Antipsychotic Medication Saphris (asenapine) Sublingual Tablets

September 13, 2010

• FDA Approves New Dosing for Faslodex (fulvestrant) Injection in Treatment of Metastatic Breast Cancer in HR+ Postmenopausal Women
• FDA Approves Pediatric Use of Protopam Chloride Chemical Poisoning Treatment

September 25, 2010

• Allergan Receives FDA Approval for Ozurdex as Treatment Option for Non-Infectious Uveitis Affecting the Posterior Segment of the Eye

October 13, 2010

• FDA Approves Vivitrol to Treat Opioid-dependent Patients

October 15, 2010

• FDA Approves H.P. Acthar Gel for the Treatment of Infantile Spasms
• FDA Approves Botox to Treat Chronic Migraine

October 18, 2010

• U.S. Food and Drug Administration Approves Baraclude (entecavir) as a Treatment for Chronic Hepatitis B Patients with Evidence of Decompensated Liver Disease

October 20, 2010

• FDA Approves Herceptin For HER2-Positive Metastatic Stomach Cancer

October 28, 2010

• FDA approves additional medical indication for Sprycel

November 1, 2010

• FDA Approves New Indication for Afinitor

November 5, 2010

• FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain

November 15, 2010

• FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents

November 19, 2010

• Prism Pharmaceuticals Receives FDA Approval of Ready-to-Use Nexterone (Amiodarone HCl) Premixed Injection

December 2, 2010

• Cubist Pharmaceuticals Receives FDA Approval for 2-Minute IV Injection of Cubicin

December 14, 2010

• FDA Approves Prezista/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations

December 22, 2010

• FDA: Gardasil Approved to Prevent Anal Cancer