FDA clears Zydus Cadila to market generic versions of Mayne Pharma's Doryx, Takeda's Uloric

Zydus Cadila announced Monday that the FDA granted the company final approval to market the delayed-release formulation of doxycycline hyclate to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. The drug is a generic version of Mayne Pharma's Doryx. Zydus Cadila added that the US regulator also issued tentative approval for febuxostat, which Takeda markets as Uloric, to treat hyperuricaemia in adults suffering from gout. 

According to the Indian drugmaker, doxycycline hyclate will be manufactured at the company's formulations manufacturing facility in the Special Economic Zone in Ahmedabad, India, while febuxostat will be produced at its plant in Moraiya, Ahmedabad. 

Zydus Cadila noted that it "now has 241 approvals and has so far filed over 340 [abbreviated new drug applications] since the commencement of the filing process in fiscal year 2003-2004." 

Other recent US approvals for the company include generic versions of Amneal Pharmaceuticals' Albenza (albendazole) to treat tapeworm infections and Pfizer's Lyrica (pregabalin) to help control certain kinds of seizures, painful nerve diseases and fibromyalgia. It has also gained recent FDA approval for generic versions of Takeda's proton pump inhibitor Prevacid (lansoprazole), as well as Boehringer Ingelheim's diabetes drug Tradjenta (linagliptin).