ARTICLE | Company News

FDA approves Orexo's Zubsolv for opioid addiction

July 5, 2013 11:36 PM UTC

FDA approved an NDA for Zubsolv buprenorphine/naloxone from Orexo AB (SSE:ORX) for maintenance treatment of opioid dependence. The company plans to launch the product -- a sublingual tablet formulation of buprenorphine and naloxone -- in the U.S. in September. The application was approved under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...