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news.Alpharma, a specialty pharmaceutical company, has resubmitted its new drug application for Embeda capsules to the FDA.
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On February 28, 2008, the company has announced the initial submission of an NDA for Embeda capsules and on April 21, 2008 announced the withdrawal of that new drug application (NDA) due to certain technical issues around data presentation.
While the initial submission qualified for a priority review, the technical issues prevented a complete evaluation by the FDA. Alpharma is fully committed to collaborating with the FDA to complete a timely review of the Embeda capsules NDA, and continues to anticipate a first quarter 2009 launch following approval.
Embeda capsules were developed with Alpharma’s proprietary technology, which combines an extended-release opioid with sequestered naltrexone, an opioid antagonist.