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.

  Arrow International, Bristol-Myers Squibb, Celgene, India, lenalidomide, Multiple myeloma, Myelodysplastic syndrome, myelodysplastic syndromes, Natco Pharma, REVLIMID, Teva Pharmaceutical Industries, US Food and Drug Administration