Natco receives FDA nod for 2 generics

The Food and Drug Administration has given Natco the green light for two generics, as well as a tentative approval for two additional strengths of one of these products.

The company has received the FDA’s stamp of approval for lenalidomide capsules in dosage strengths of 5 mg, 10 mg, 15 mg, and 25 mg strengths, and tentative approval of the 2.5-mg and 20-mg strengths. 

It is used to treat adults with multiple myeloma in combination with the medicine dexamethasone, or as maintenance treatment after autologous hematopoietic stem cell transplantation (a type of stem cell transplant that uses your own stem cells). 

Natco and its marketing partner Arrow International, an affiliate of Teva, 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 Pharma’s marketing partner, Breckenridge, has received the FDA nod for everolimus tablets. The product is the generic of Zortress.

BPI plans to launch 0.25-mg, 0.5-mg and 0.75-mg strengths of the product shortly.

The medication is indicated in the prophylaxis of organ rejection in kidney transplantation and liver transplantation. 

Zortress and its generics had a market value of $162 million during the 12 months ended March 2021, according to the company.