News

FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.

FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

FDA has approved Watson’s lidocaine topical patch 5%, the first generic version of Lidoderm (Endo) for the relief of pain associated with post-herpetic neuralgia.

FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.

FDA approved Mylan Pharmaceutical's 15-mg, 30-mg, and 45-mg pioglitazone hydrochloride tablets, the first generic version of Actos (Takeda), along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

FDA has placed a partial clinical hold on Idenix Pharmaceuticals' nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus.