Natco Pharma Limited has received the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules from the US Food and Drug Administration (FDA).
Hyderabad-based Natco, along with its marketing partner Arrow International Limited (a US affiliate of Teva Pharmaceutical Industries Ltd), 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’s marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its ANDA for Everolimus tablets (generic for Zortress) from the USFDA. BPI plans to launch 0.25 mg, 0.5 mg and 0.75 mg strengths of the product shortly.
The above strengths of the drug are indicated in the Prophylaxis of Organ Rejection in Kidney Transplantation and Liver transplantation, according to a release.
As per industry sales data, Zortress and its therapeutic equivalents had generated annual sales of $162 million during the twelve months ending March 2021 in the US.