FDA publishes finalized guidance for buprenorphine depots

This article was originally published here

FDA-logo-newThe FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder.

The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) pathway.

Get the full story at our sister site, Drug Delivery Business News.

The post FDA publishes finalized guidance for buprenorphine depots appeared first on MassDevice.

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