Pfizer announced that the FDA has approved a Prior Approval Supplement for Embeda (morphine sulfate and naltrexone HCl) Extended-Release Capsules. 

Embeda is a Schedule II narcotic indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

RELATED: Pain Management Resource Center

Embeda was voluntarily recalled in March 2011 because it did not meet a prespecified stability requirement during routine testing. The Prior Approval Supplement included an update to the Embeda manufacturing process that addressed the pre-specified stability requirement.

Embeda extended-release capsules will be available in 20mg/0.8mg and 30mg/1.2mg as 75-count bottles; 50mg/2mg as 150-count bottles; 60mg/2.4mg and 80mg/3.2mg as 200-count bottles; and 100mg/4mg as 300-count bottles. Pfizer anticipates it will be available in the second quarter of 2014.

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