NATCO gets US FDA nod for Everolimus tablets

Natco Pharma’s marketing partner, Breckenridge Pharmaceutical, has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for Afinitor) from the US Food and Drug Administration (USFDA).

NATCO’s partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks. The launch of 10 mg strength of the product is subject to confidential terms of a settlement and license agreement entered into with the owner of the Afinitor brand. The launch date of 10 mg strength of the product will be announced at a later date.

The above strengths of Everolimus are indicated in the treatment of breast cancer and a few other types of cancers. As per industry sales data, Afinitor and its therapeutic equivalents had generated annual sales of $712 million in US during the twelve months ending December 2020.