The company has received final approval from the US Food and Drug Administration (USFDA) 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.
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.
In another filing, Natco said its marketing partner Breckenridge Pharmaceutical Inc has received final approval for its ANDA for Everolimus tablets from the US health regulator.
Breckenridge Pharmaceutical Inc plans to launch the tablets in strengths of 0.25 mg, 0.5 mg and 0.75 mg shortly, it added.
These strengths of Everolimus are indicated in the prophylaxis of organ rejection in kidney and liver transplants, Natco Pharma said.
As per industry sales data, Zortress (Everolimus) and its therapeutic equivalents generated annual sales of USD 162 million during the twelve months ended March 31, 2021 in the US, it added.