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Pfizer Inc Receives FDA Approval For Prior Approval Supplement For EMBEDA

Monday, 4 Nov 2013 05:14pm EST 

Pfizer Inc announced 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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19 Dec 2014