Natco Pharma gets USFDA approval for lenalidomide capsules

Natco Pharma has received final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 5 mg, 10 mg, 15 mg, and 25 mg strengths, from the US Food and Drug Administration (FDA), and tentative approval for the 2.5 mg and 20 mg strengths.

NATCO, along with its marketing partner Arrow International (a US affiliate of Teva Pharmaceutical Industries), previously settled the Paragraph IV litigation related to the product with Celgene (now part of Bristol-Myers Squibb), who sells the product under the brand-name REVLIMID. NATCO and Arrow shall launch the product on agreed-upon launch dates in the future.