Pharmaceutical Business review

Impax generic Doryx 75, 100mg tablets get final FDA nod

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.

Impax plans to launch Doryx through its generic division Global Pharmaceuticals.

Warner Chilcott and Mayne Pharma International have filed suit against Impax in the US District Court for the District of New Jersey, alleging patent infringement for the filing of Impax’s ANDA, in 2008.