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Natco Pharma gets FDA approval for Lenalidomide Capsules

bySrinath
May 24, 2021
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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 gets FDA approval for Lenalidomide Capsules
Natco Pharma gets FDA approval for Lenalidomide Capsules. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

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

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