HAYWARD, Calif. — Impax Laboratories Inc. has received final approval from the Food and Drug Administration for 75-mg and 100-mg doxycyline hyclate delayed-release tablets, a generic version of the antibacterial medication Doryx.
Impax said Wednesday that the company plans to launch the product through Global Pharmaceuticals, its generics division.
The company noted that in December 2008, Warner Chilcott Ltd. and Mayne Pharma International Pty. Ltd. filed suit against Impax in the U.S. District Court for New Jersey, alleging patent infringement for the filing of the company’s abbreviated new drug application (ANDA) for the product, and that 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, alternative treatment for selected infections when penicillin is contraindicated, adjunctive therapy in acute intestinal amebiasis and severe acne, and prophylaxis of malaria, according to Impax.
U.S. sales of Doryx 75-mg and 100-mg tablets totaled about $25 million for the 12 months ended in October, Impax reported, citing data from Wolters Kluwer Health.
