Elite Pharmaceuticals Inc. has received the US Food and Drug Administration approval for its 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 US sales of approximately $30 million according to IMS Health Data.