Natco Pharma has received final approval from the U.S. Food and Drug Administration for abbreviated new drug applications (ANDA) for two products, including an anti-cancer drug for which the company and its marketing partner had settled a litigation with Celgene.
On Lenalidomide capsules, which is indicated in treatment of certain types of cancers, Natco said it has received final approval for 5mg, 10mg, 15mg, and 25mg strengths and tentative approval of the 2.5 mg and 20mg strengths.
Along with marketing partner Arrow International, which is a U.S. affiliate of Teva Pharmaceutical Industries, the company had previously settled the Paragraph IV litigation, related to the product, with Celgene (now part of Bristol-Myers Squibb). Celgene sells the product under the brand-name Revlimid.
Natco and Arrow will launch the approved product on agreed-upon launch dates in the future, a release said.
In another release, Natco said marketing partner, Breckenridge Pharmaceutical Inc (BPI), has received final approval for its ANDA for Everolimus tablets (generic for Zortress), from the regulator.
BPI plans to launch 0.25mg, 0.5mg and 0.75mg strengths of the product shortly, which 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 U.S., Natco said.
