Elite Pharmaceuticals Announces FDA Approval of Supplemental Application for Hydromorphone

Elite Pharmaceuticals, Inc. ("Elite")

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.