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Pharmaceuticals / Regulatory Affairs

FDA Lays Out Final Guidance for Buprenorphine Pumps, Injections

Feb. 14, 2019

Sponsors may not have to conduct new efficacy trials for the anti-opioid treatment buprenorphine injections or implants if there are existing data for similar products, the FDA said in a final guidance.

Buprenorphine — most commonly known by the brand-name Suboxone — is one of three drugs, including methadone and naltrexone, to be approved for medication-assisted treatment for opioid addicts.

The FDA approved the first combination buprenorphine injection devices/medicines two years ago and now says it wants to clarify expectations for other delivery mechanisms.

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