Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Hydromorphone

Elite Pharmaceuticals, Inc. ("Elite") (OTCBB: ELTP) announced today that on January 23, 2012, the U.S. Food and Drug Administration approved the Company's supplemental application for the manufacturing and packaging of Hydromorphone Hydrochloride USP 8 mg. 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. Hydromorphone hydrochloride is a member of the opioid analgesic and antitussive class. It is a pure opioid agonist used primarily for pain relief or as a cough suppressant. For the twelve months ending September 2011, Dilaudid® 8 mg tablets and its generic equivalents had total U.S. sales of approximately $30 million according to IMS Health Data.