Natco Pharma said its marketing partner Breckenridge Pharmaceutical Inc has received final approval from the US health regulator for cancer treatment drug Everolimus. The approved product is a generic for Afinitor.
“Breckenridge Pharmaceutical Inc (BPI) has received final approval for its abbreviated new drug application (ANDA) for Everolimus tablets from the US Food and Drug Administration (USFDA),” Natco Pharma said in a regulatory filing.
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 l0 mg strength of the product is subject to confidential terms of a settlement and licence agreement entered into with the owner of the Afinitor brand, Natco said, adding that the launch date of l0 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.
Quoting industry sales data, Natco Pharma said Afinitor and its therapeutic equivalents had generated annual sales of USD 712 million in USA during the twelve months ending December 2020.
Shares of Natco Pharma were trading 6.45 per cent higher at Rs 886.50 apiece on the BSE.