Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has granted final approval to Impax Laboratories’ abbreviated new drug application (ANDA) for the generic version of Doryx (doxycyline hyclate delayed-release) 75 and 100mg tablets.
Subscribe to our email newsletter
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.