Corporate News     14-Jun-21
Natco Pharma receives USFDA approval for Carfilzomib Vials ANDA
Natco Pharma has received approval for its Abbreviated New Drug Application (ANDA) for Carfilzomib Vials ANDA (generic for KYPROLIS® ), from the U.S. Food and Drug Administration (USFDA).

The parties have received final approval for 10mg and 60mg strengths of the product and tentative approval for 30mg strength of the product. Based on the ANDA filing date NATCO believes that it is eligible for 180 days of sole generic marketing exclusivity for the 10mg strength and shared 180 days of generic marketing exclusivity for the 60mg strength of the product at the time of launch.

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