Friday, February 22, 2013

News: FDA denies Reckitt's request to block generic buprenorphine/naloxone tablets

The U.S. Food and Drug Administration has roundly denied all requests from Reckitt-Benckiser to block approval of generic buprenorphine/naloxone tablets. This request was made at the time when the monopoly on the product was ending and was based on risks of pediatric exposures that the company claimed were higher with the tablet than their new film product. The FDA provided an excellent review of the issues and rejected all components of the request.

This is an enormous relief for public health agencies providing buprenorphine services, many of which would have dropped buprenorphine services altogether or would have ceased to provide the buprenorphine/naloxone formulation due to cost.

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