FDA approves Impax's ANDA for generic Doryx 75 and 100mg tablets

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Dec 29 2010

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx® (doxycyline hyclate delayed-release) 75 and 100mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

In December 2008, Warner Chilcott Limited and Mayne Pharma International Pty. Ltd. filed suit against the Company in the U.S. District Court for the District of New Jersey, alleging patent infringement for the filing of the Company's ANDA. Litigation is ongoing.

Doryx® is a tetracycline-class antibacterial indicated for rickettsial infections, sexually transmitted infections, respiratory tract infections, specific bacterial infections, ophthalmic infections, anthrax, including inhalational anthrax (post-exposure), alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria. According to Wolters Kluwer Health, U.S. sales of Doryx® 75 and 100 mg were approximately $25 million in the 12 months ended October 2010.

SOURCE Impax Laboratories, Inc.

Posted in: Disease/Infection News | Pharmaceutical News

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