King Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) is continuing its review of the New Drug Application (NDA) for Embeda (morphine sulfate and naltrexone hydrochloride) extended release capsules. It is likely that this review will extend into early 2009.
"Our discussions with the FDA continue to progress and we remain confident in the strength of our regulatory submission," said Eric Carter, chief science officer of King Pharmaceuticals. "We look forward to working closely with the agency as needed throughout the review process."
Utilizing King's proprietary technology, Embeda Capsules contain extended-release morphine pellets, each with a sequestered core of naltrexone, an opioid antagonist.