Pfizer announced that the FDA has approved a Prior Approval Supplement for Embeda (morphine sulfate and naltrexone HCl) Extended-Release Capsules.
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.
For more information call (800) 438-1985 or visit Embeda.com.