November, 2009:

• Orphan drug designation granted for amifampridine phosphate for Lambert Eaton Myasthenic Syndrome (LEMS)
• Phase 1 study of Advax AIDS vaccine delivery by electroporation
• Agriflu seasonal influenza vaccine approved
• Cymbalta approved for maintenance treatment of generalized anxiety disorder (GAD)
• Intelence granted traditional approval by FDA for HIV
• BLA submitted for Zalbin, a treatment for chronic hepatitis C (HCV)
• FDA accepts NDA for extended release Aricept, a treatment for Alzheimer's disease (AD)
• Revised Peramivir IV renal dosing recommendations for H1N1 influenza
• Phase 2 trial of plinabulin (NPI-2358) for the treatment of advanced non-small cell lung cancer (NSCLC)
• Phase 2 study of LX1031 for the treatment of non-constipating irritable bowel syndrome (IBS)
• Phase 2b/3 study of Cinquil for pediatric eosinophilic esophagitis (EoE)
• Naprelan Dose Card blister packs launched
• Abilify approved for irritability associated with autistic disorder
• FDA to evaluate risk of cardiovascular events with sibutramine
• Geodon approved for adjunctive maintenance treatment of bipolar I disorder
• Intravenous Revatio approved for pulmonary arterial hypertension (PAH)
• Vicks Sinex UltraFine Mist Nasal Spray recalled
• NDA submitted for Brilinta for acute coronary syndromes
• RockHard Weekend dietary supplement recalled
• IDS Sports brand dietary supplements recalled
• FDA approves additional vaccine for 2009 H1N1 (swine) influenza virus
• FDA warns of drug interaction with clopidogrel and omeprazole
• Qutenza approved for postherpetic neuralgia (PHN)
• Phase 3 study of extended-release injectable naltrexone for treatment of opioid dependence
• Phase 2 study of Civamide Patch for post-herpetic neuralgia (PHN)
• Phase 3 study of lomitapide (AEGR-733) to lower LDL cholesterol
• Phase 3 study of picoplatin in small cell lung cancer (SCLC)
• Phase 3 study of D-tagatose for the treatment of type 2 diabetes
• Lysteda approved for heavy menstrual bleeding
• Lusedra available for monitored anesthesia care sedation
• Pai You Guo dietary supplement recalled
• FDA warns of chondrolysis with continuously infused local anesthetics
• FDA warns of particulate contamination of Genzyme injectable products
• Patient enrollment completed for first of two Phase 3 trials for SCH 530348 for acute coronary syndrome (ACS)
• CSL Biotherapies' H1N1 and seasonal influenza vaccines approved for children
• Redesigned Assure Pro Blood Glucose Monitor Test Strips available
• Prevacid 24HR available over-the-counter
• Hospira recalls propofol and Liposyn products
• Recall of Tylenol Arthritis Pain Caplet
• Intuniv available for ADHD
• Phase 1b study of CTP-518 for HIV
• Istodax approved for cutaneous T-cell lymphoma
• Reyataz labeling updated to include long-term data in treatment-naive adults with HIV
• FDA warns of undeclared drug ingredient in Stiff Nights dietary supplement
• Glucocard Vital blood glucose monitoring system approved
• Orphan drug designation granted to Abraxane for pancreatic cancer and Stage IIB-IV melanoma
• Orphan drug designation granted to voreloxin for acute myeloid leukemia (AML)
• Pennsaid Topical Solution approved for osteoarthritis of the knee
• Citracal Calcium Plus Heart Health supplement available
• American Regent expands ketorolac tromethamine injection recall
• Orphan drug designation granted to TNFerade for pancreatic cancer
• Bodybuilding.com brand dietary supplements recalled
• Results from two Phase 3 studies for linaclotide for patients with chronic constipation (CC)
• FDA warns of renal failure with Byetta
• Focalin XR 30mg approved for attention deficit hyperactivity disorder (ADHD)
• Endpoints reached in second of two Phase 3 studies of Benlysta for systemic lupus erythematosus (SLE)
• Vicks DayQuil Plus Vitamin C and NyQuil Plus Vitamin C unlawfully marketed
• NCCN Guidelines for Colorectal Cancer Screening updated
• Byetta gains expanded indication for first-line treatment for type 2 diabetes