Natco partner's cancer drug gets FDA nod

Hyderabad: Hyderabad-Natco Pharma on Monday said its marketing partner Breckenridge Pharmaceutical Inc has received approval from the US health regulator for anti-cancer drug Carfilzomib Vials.

"Breckenridge Pharmaceutical Inc. (BPI), has received approval for its abbreviated new drug application (ANDA) for Carfilzomib Vials ANDA (generic for Kyprolis), from the US Food and Drug Administration (USFDA)," Natco Pharma said in a regulatory filing. Natco has tied up with Breckenridge Pharmaceutical Inc to market the product in the US.

"The parties have received final approval for 10 mg and 60 mg strengths of the product and tentative approval for the 30 mg strength of the product," it added. Natco Pharma said based on the ANDA filing date, the company believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10 mg strength and shared 180 days of generic marketing exclusivity for the 60 mg strength of the product at the time of launch.