From staff reports


New online tool available for Janssen products

October 01, 2012

Janssen Pharmaceuticals, Inc. is making it easier for pharmacists and healthcare professionals to look up drug information by launching an online scientific resource tool.

FDA approves Humira to treat ulcerative colitis

October 01, 2012

FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.

FDA approves regorafenib tablets for treatment of metastatic colorectal cancer

September 27, 2012

FDA 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).

FDA task force to work on antibacterial drug development

September 26, 2012

FDA is supporting antibacterial drug development by launching a new internal task force, according to a press release today.

FDA grants priority review to opioid-induced constipation indication for lubiprostone

September 26, 2012

FDA 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.

Hydrocodone bitartrate and acetaminophen lots recalled for potential for oversized, superpotent tablets

September 25, 2012

Watson Laboratories issued a voluntary nationwide recall for 2 lots of hydrocodone bitartrate and APAP Tablets, USP 10 mg/500 mg. Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.