The U.S. Food and Drug Administration approved the first generic versions of Indivior PLC's Suboxone film, which dissolves under the tongue and is used to treat opioid dependence.
Suboxone is a combination of buprenorphine and naloxone. The agency granted approvals to Mylan NV unit Mylan Technologies Inc. and Dr. Reddy's Laboratories Ltd. unit Dr. Reddy's Laboratories SA to market buprenorphine and naloxone sublingual film in multiple strengths.
FDA Commissioner Scott Gottlieb said the regulator plans to promote the development of better drugs for opioid use disorder and facilitate market entry of generic versions of approved drugs to help ensure broader access.
"The FDA is also taking new steps to address the unfortunate stigma that's sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction," Gottlieb said.