UPDATE 1-Alpharma withdraws application for painkiller, shrs hit

Mon Apr 21, 2008 11:19pm BST
 
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April 21 (Reuters) - Alpharma Inc (ALO.N: Quote, Profile, Research) said it will withdraw the application seeking approval for its painkiller, Embeda, due to certain issues that prevented a complete evaluation by U.S. health regulators in the allotted time.

Shares of the Bridgewater, New Jersey-based company fell about 6 percent to $25.71 in trading after the bell. They closed at $27.21 Monday on the New York Stock Exchange.

The application, which the company had submitted in February, had a "priority review" status, which meant the drug would be evaluated within six months as opposed to 10 to 12 months that it ususally takes for a product to be approved or rejected by the U.S. Food and Drug Administration.

Alphmarma said it expects to resubmit the application after addressing the issues and re-qualify for priority review.

The specialty pharmaceutical company continues to target the product launch in the first quarter of 2009 following approval. (Reporting by Varsha Tickoo in Bangalore; Editing by Deepak Kannan)

 

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