Elite Pharmaceuticals, Inc. (ELTP) said Wednesday that the U.S. Food and Drug Administration has approved the company's supplemental application for the manufacturing and packaging of naltrexone hydrochloride 50 mg tablets.
The approval will allow the company to commence the commercial manufacturing and packaging of the product for its sales and marketing partner, which will distribute the product as part of a multi-product distribution agreement.
Naltrexone is an opioid receptor antagonist used mainly in the management of alcohol dependence and opioid addiction.
For the twelve months ending December 31, 2012, Revia and its generic equivalents had total U.S. sales of about $16 million according to IMS Health Data.
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