FDA Actions in Brief September 2012
October 1st 2012Recent FDA Approvals (through August 2012) related to (Innocutise, Genzyme, Sanofi, Pfizer, Amgen, Astellas Pharma US, Medivation, Gilead Sciences, Ironwood Pharmaceuticals, Forest, Reckitt Benckiser, Boehringer Ingelheim, Eli Lilly, Sicor Biotech UAB, Teva Corporation, Novartis)
Read More
Prepopik (Sodium picosulfate and magnesium oxide and anhydrous citric acid for oral solution)
October 1st 2012New molecular entity: FDA approved the combination of sodium picosulfate (a stimulant laxative) and magnesium oxide and anhydrous citric acid (which form magnesium citrate, an osmotic laxative) (Prepopik, Ferring Pharmaceuticals) for cleansing of the colon as a preparation for colonoscopy in adults.
Read More
Current standards and future treatments of rheumatoid arthritis
October 1st 2012Rheumatoid arthritis is an autoimmune disorder in which the immune system targets synovial joints and causes mild-to-severe joint disease with extra-articular manifestations. This review discusses the current standards of care and details the data being collected on new agents.
Read More
FDA approves regorafenib tablets for treatment of metastatic colorectal cancer
September 27th 2012FDA approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy).
Read More
FDA grants priority review to opioid-induced constipation indication for lubiprostone
September 26th 2012FDA has given priority review to an additional indication for lubiprostone (Amitiza, Sucampo Pharmaceuticals and Takeda) for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Read More