Alpharma Inc. Announces the Resubmission of a New Drug Application for EMBEDA(TM) Capsules

BRIDGEWATER, NJ--(Marketwire - June 30, 2008) - Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, today announced that it has resubmitted its New Drug Application (“NDA”) for EMBEDA™ (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules to the U.S. Food and Drug Administration (the “FDA”). On February 28, 2008, the Company announced the initial submission of an NDA for EMBEDA™ Capsules and on April 21, 2008 announced the withdrawal of that 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.

MORE ON THIS TOPIC