ELITE PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF SUPPLEMENTAL APPLICATION FOR NALTREXONE
NORTHVALE, N.J. – February 6, 2013 – Elite
Pharmaceuticals, Inc. ("Elite”) (OTCBB: ELTP) announced today that on
January 31, 2012, the U.S. Food and Drug Administration approved the
Company’s supplemental application for the manufacturing and packaging
of naltrexone hydrochloride 50 mg tablets. This approval will allow the
Company to commence the commercial manufacturing and packaging of this
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
primarily 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 approximately $16 million according
to IMS Health Data.
Why is this important? This is a golden opportunity for the growing Elite. They have a chance of reaching into the market for this drug giving them more leverage as they create a money stream heading north.
