NEW DELHI: Natco Pharma on Saturday said it has received approval from the US health regulator for generic Lenalidomide capsules indicated for treatment of adults with multiple myeloma, mantle cell lymphoma and myelodysplastic syndromes.
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.
It added that 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'.
The filing said that Natco and Arrow shall launch the product on agreed-upon launch dates in the future. 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.
It added that Breckenridge Pharmaceutical Inc plans to launch the tablets in strengths of 0.25 mg, 0.5 mg and 0.75 mg shortly. Natco Pharma said that these strengths of Everolimus are indicated in the prophylaxis of organ rejection in kidney and liver transplants.
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.