Wednesday, September 1, 2010

Natco files ANDA for lenalidomide capsules

Natco Pharma, a Hyderabad based pharma major, has filed an abbreviated new drug application (ANDA) with the US FDA for approval to market lenalidomide capsules in 5, 10, 15 and 25 mg strengths prior to the expiration of various US patents. Natco's lenalidomide capsules are the generic version of Celgene Corporation's Revlimid.


Acccording to company they are the first filer with providing paragraph IV certification and therefore will be awarded with 180 day exclusivity.

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