Pfizer Receives FDA Approval for a Prior Approval Supplement

Pfizer Inc. (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.

EMBEDA is not for use as an as-needed (prn) analgesic, for pain that is mild or not expected to persist for an extended period of time, for acute pain, for postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Read more.