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Natco Pharma marketing partner BPI gets USFDA nod for anti-cancer drug

Drugmaker Natco Pharma’s marketing partner, Breckenridge Pharmaceutical (BPI), has received final approval for its abbreviated new drug application for Everolimus Tablets from the U.S. Food and Drug Administration.

The product is a generic version of Afinitor and indicated in the treatment of breast cancer and a few other types of cancers. BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product within the next few weeks.

The launch of 10 mg strength is subject to confidential terms of a settlement and licence agreement with owner of the Afinitor brand. The launch date will be announced later, Natco Pharma said on Monday. A release from the company, citing industry sales data, said Afinitor and its therapeutic equivalents had generated annual sales of $712 million in the U.S. during 2020.

A subsidiary of Towa Pharmaceutical of Japan, BPI collaborates with manufacturers globally for cost-effective generic pharmaceuticals to the U.S. patients.

Nod for MSN’s generic for Saphris

On Sunday, another drugmaker from Hyderabad MSN Group, which also has a marketing partnership with BPI, had announced receipt of final approval for its ANDA for Asenapine Sublingual Tablets, in 5 mg strength from the USFDA.

The approved product is a generic for Saphris and indicated for the treatment of schizophrenia and bipolar disorder.

MSN had previously received final approval for 2.5 mg and 10 mg strengths of the same product. The product will be launched by BPI. According to industry sales data, Asenapine had annual sales of $239 million during the twelve months ended September 2020, a release from MSN said.

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Printable version | Apr 16, 2021 12:52:36 PM | https://www.thehindu.com/business/natco-pharma-marketing-partner-bpi-gets-usfda-nod-for-anti-cancer-drug/article34022425.ece

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