NATCO receives final approval for Everolimus tablets for the US market
(Time Zone: Arizona, USA)
Natco Pharma Limited (NSE: NATCOPHARM; BSE: 524816) has announced that its marketing partner, Breckenridge Pharmaceutical Inc. (BPI), has received final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets (generic for Afinitor®) from the U.S. 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 10mg 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 10mg 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 ind ustry sales data, Afinitor® and its therapeutic equivalents had generated annual sales of $712 million in USA during the twelve months ending December 2020.
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