USFDA approves Natco’s Lenalidomide capsules
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced that its Connecticut-based marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for ZORTRESS ®),from the U.S. Food and Drug Administration (USFDA).
BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly. said Natco in a release on 22 May 2021.
The above strengths of Everolimus are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver Transplantation.
As per industry sales data, ZORTRESS® and its therapeutic equivalents had generated annual sales of $162million during the twelve months ending March 2021 in the US.
Also, the US Food and Drug Administration (USFDA) has given approval to Natco for generic Lenalidomide capsules indicated for treatment of adults with multiple myeloma, mantle cell lymphoma and myelodysplastic syndromes.
The approval is for its abbreviated new drug application (ANDA) for Lenalidomide capsules in 5 mg, 10 mg, 15 mg, and 25 mg strengths, and tentative approval for the capsules in strengths of 2.5 mg and 20 mg, Natco Pharma said in a regulatory filing with BSE and NSE.
Natco, along with its marketing partner Arrow International 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’, it added.
Natco and Arrow shall launch the product on agreed-upon launch dates in the future, the filing said. #health #manufacturing #exports /fiinews.com
