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You are here:  Home / Business News / Drug gets FDA approvable letter

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Drug gets FDA approvable letter

Published: Dec. 30, 2005 at 7:34 PM
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CAMBRIDGE, Mass., Dec. 30 (UPI) -- A Cambridge, Mass., biotech company has received an approvable letter from the U.S. government for an injectable treatment for alcoholism.

Alkermes Inc. (NASDAQ:ALKS) received conditional approval from the Food and Drug Administration Wednesday for Vivitrol, an injectable form of an oral medication, naltrexone, long prescribed to treat alcoholism, reported the Wall Street Journal Friday.

Alkermes Chief Executive Richard Pops said Vivitrol that the company expects to introduce the drug in the second quarter of 2006.

The company will form a partnership with Cephalon Inc. (NASDAQ:CEPH), of Frazer, Pa., to market Vivitrol.

The company must provide additional data and finalize labeling to gain full FDA approval for the drug, which is designed to be administered by physicians. One dose lasts one month and treatment is to be accompanied by counseling.



© 2005 United Press International, Inc. All Rights Reserved.
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