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news.Impax Laboratories, a specialty pharmaceutical company, has submitted an abbreviated new drug application for doxycyline hyclate delayed-release tablets 150mg, generic of Doryx, to the FDA.
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Once the abbreviated new drug application (ANDA) is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialize the products.
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.