Natco Pharma gets FDA approval for Lenalidomide Capsules

Natco Pharma has secured the final approval from the US Food and Drug Administration (FDA) of its abbreviated new drug application (ANDA) for Lenalidomide Capsules, 5mg, 1 Omg, 15mg, and 25mg, and the tentative approval of the 2.5mg and 20mg.

Lenalidomide Capsules is the generic for Bristol-Myers Squibb’s REVLIMID, which is indicated in the US for the treatment of multiple myeloma and myelodysplastic syndromes.

The Indian pharma company and its marketing partner Arrow International, a US affiliate of Teva Pharmaceutical Industries had previously settled a litigation pertaining to the product with Celgene, which was acquired by Bristol-Myers Squibb.

Natco Pharma and Arrow International plan to roll out Lenalidomide Capsules on agreed-upon launch dates in the future.