FDA approves Prior Approval Supplement for EMBEDA Extended Release Capsules CII

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Nov 4 2013

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for EMBEDA^® (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII.

The Prior Approval Supplement included an update to the EMBEDA manufacturing process that addressed the pre-specified stability requirement that led to the voluntary recall of EMBEDA from the market in March 2011. Pfizer anticipates product availability in the second quarter of 2014.

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Pfizer Inc.

Posted in: Pharmaceutical News

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