7 September 2018 - Agency is taking additional steps to advance the development of new FDA approved treatments for opioid dependence and encourage their more widespread use.

The U.S. FDA today approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 mg/4 mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.

The FDA granted approval of Cassipa to Teva Pharmaceuticals.

Read FDA press release