January, 2011:

• Gralise approved for treatment of post-herpetic neuralgia (PHN)
• Rituxan gains indication for first-line maintenance use in follicular lymphoma
• Nuedexta available for pseudobulbar affect
• Phase 3 study of iniparib for the treatment of metastatic triple-negative breast cancer (mTNBC)
• FDA accepts NDA for Remoxy for moderate to severe chronic pain
• FDA Video: New Pediatric Dosing Recommendations for Valcyte
• FDA Video: Diabetes/Cardiovascular Risk with Prostate Cancer Drugs
• FDA Video: New Precaution when Calculating Carboplatin Doses
• FDA Video: Update on Femur Fracture Risk with Bisphosphonates
• Phase 3 Study of Masitinib for the Treatment of Asthma
• Phase 2b study update of ANA598 for hepatitis C (HCV)
• FDA reviews possible risk of anaplastic large cell lymphoma (ALCL) with breast implants
• Relistor Kit packaging affected by Triad Group alcohol prep pad recall
• Allegra and Allegra-D Approved for Over-The-Counter Use
• Phase 2b study of Serdaxin for the treatment of major depressive disorder (MDD)
• Orphan drug designation granted to Melanoma Cancer Vaccine from BioSante
• FDA accepts NDA for fidaxomicin, a treatment for Clostridium difficile infection (CDI)
• Phase 3 trial of AZ-004 for the treatment of agitation associated with schizophrenia
• Fast track designation granted to MuDelta for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d)
• Phase 3 study of eritoran for the treatment of severe sepsis
• Saphris gains indications
• Phase 2 studies of PEP02 for the treatment of gastric and pancreatic cancer
• FDA determines no cancer risk associated with Lantus
• FDA warns against Celerite Slimming Capsules
• Daily Omega supplements available
• Arixtra Starter Kits may contain recalled Triad alcohol prep pads
• Phase 2/3 study of peretinoin for the treatment of hepatocellular carcinoma (HCC)
• Phase 1/2 study of FG-3019 for the treatment of pancreatic cancer
• Phase 2 study of HyperAcute Pancreas for the treatment of pancreatic cancer
• Viibryd approved for major depressive disorder
• Orphan drug designation granted to RiVax for prevention of ricin intoxication
• Phase 1/2 study of PVS-10200 for restenosis associated with angioplasty or stent procedures
• Phase 3 study of levomilnacipran for the treatment of major depressive disorder (MDD)
• Phase 2 study of imetelstat for the treatment of essential thrombocythemia (ET)
• Phase 1/2 study of BMN 701 for the treatment of Pompe disease
• Phase 1/2 study of resminostat (4SC-201) for the treatment of advanced and metastatic colorectal cancer
• Phase 2 study of TC-5619 for cognitive dysfunction associated with schizophrenia
• Phase 3 study of PLX4032 for the treatment of metastatic melanoma
• NDA resubmitted for Intermezzo for insomnia
• Phase 2 study of Reolysin for the treatment of pancreatic cancer
• Natroba topical suspension approved for head lice treatment
• Ofirmev (acetaminophen) injection available
• DaTscan radiopharmaceutical agent approved for detection of dopamine transporters
• Phase 2 study of ADXS11-001 for the treatment of cervical dysplasia
• FDA warns of potential risk of severe liver injury with Multaq
• New Package Sizing for Qvar Metered Dose Inhaler
• Merck announces changes to Phase 3 studies of vorapaxar for prevention of cardiac events
• Phase 3 study of Exparel for postoperative analgesia
• Phase 3 study of peramivir for the treatment of influenza
• FDA approves new formulation of Acetadote
• FDA limits acetaminophen in prescription combination products
• Phase 3 study of GSK'786 for the treatment of Crohn's disease
• Phase 3 study of ARQ 197 for non small cell lung cancer (NSCLC)
• Phase 2 study of FG-3019 for the treatment of idiopathic pulmonary fibrosis (IPF)
• FDA accepts NDA for extended-release Janumet for type 2 diabetes
• Phase 2b study of SB-509 for the treatment of diabetic neuropathy (DN)
• Phase 3 study of Aeroquin for the treatment of cystic fibrosis (CF)
• Phase 2 study of Revascor for the treatment of congestive heart failure (CHF)
• Phase 2 study of EXC 001 for the treatment of hypertrophic and fine line scarring
• Phase 2 study of ENB-0040 for the treatment of hypophosphatasia (HPP)
• Phase 2 study of ADL5945 for the treatment of opioid-induced constipation (OIC)
• Phase 3 study of Davanat for the treatment of metastatic colorectal cancer
• FDA warns of accidental morphine oral solution overdose
• Abstral transmucosal tablets approved for breakthrough cancer pain
• Triad Group recalls alcohol prep products, Betaseron users affected
• Kapvay available for ADHD
• Phase 3 study of lubiprostone for the treatment of opioid-induced bowel dysfunction (OBD)
• FDA accepts NDA for Exelbine for treatment of non-small cell lung cancer (NSCLC)
• Phase 2b study update of RDEA594 for gout
• Kombiglyze XR available for type 2 diabetes
• Teva recalls underweight metronidazole tablets
• Nexiclon XR available for treating hypertension
• Phase 2 study of TriRima for treatment resistant depression
• Phase 2 study of ETC-1002 for the treatment of dyslipidemia
• Phase 2 study of iniparib (BSI-201) for the treatment of metastatic breast cancer
• NDA submitted for rivaroxaban for the treatment of non-valvular atrial fibrillation (AF)
• CDC updates Sexually Transmitted Diseases Treatment Guidelines
• Actemra gains indication for inhibition and improvement of RA
• Phase 2 Studies of CVBT-141B for Diabetic Wounds
• Phase 2b study of ANA598 for the treatment of hepatitis C (HCV)
• Phase 2b and 3 studies of aclidinium bromide for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD)
• Glumetza 500mg available again for type 2 diabetes
• FIRST Duke's Mouthwash and FIRST Mary's Mouthwash compounding kits available
• Phase 2b study of Androxal for the treatment of secondary hypogonadism
• Phase 2 study of JVS-100 for the treatment of critical limb ischemia (CLI)
• Ritedose recalls mislabeled albuterol sulfate inhalation solution
• Phase 3 study of Multikine for the treatment of head and neck cancer
• Intelence 200mg dosage strength approved
• Cumberland recalls six lots of Acetadote injection