Everolimus Tablets: USFDA’s approval for Breckenridge

Breckenridge Pharmaceutical receives the USFDA’s approval for Everolimus tablets (an anticancer drug) on behalf of Natco Pharma :
The Hindu

Breckenridge Pharmaceutical ( BPI ) has received the USFDA’s^[1] final approval for its ANDA^[2] for Everolimus tablets. BPI is the marketing partner of Natco Pharma.

Everolimus Tablets: USFDA’s approval for Breckenridge

This drug product is the generic version of Afinitor, which is used to treat breast cancer and other cancer types. Over the next few weeks, the company plans to launch various strengths of this generic product. This includes 2.5 mg, 5 mg, and 7.5 mg strengths of the Everolimus tablets.

The launch of the 10 mg strength of the tablet depends on the owner of the Afinitor brand. This launch is subject to the confidential terms of the settlement and license agreement with the former. On 8 March 2021, Natco pharma also announced that it would disclose the launch date later.

The company also released the industry sales data of Afinitor and its therapeutic equivalents recently. It revealed that these products’ annual sales were over $ 712 million in the United States during 2020.

About BPI- a subsidiary of Towa Pharmaceuticals

BPI is a subsidiary of Towa Pharmaceuticals Inc. of Japan. This company collaborates with other manufacturers worldwide to manufacture cost–effective generic products for the US.

On 7 March 2021, another drug maker with a marketing partnership with BPI announced the receipt of USFDA’s approval for its ANDA. This company is the MSN group of Hyderabad, and the product approved is Asenapine Sublingual Tablets 5 mg.

This product is the generic version of Saphris and used in treating schizophrenia and bipolar disorder.

MSN has already received approval for the marketing of the 2. 5 mg and 10 mg strength of this tablet. BPI will launch the recently approved product in the US market. As per industry sales data, the annual sales data of Asenapine for over 12 months ending in September 2020 is around $ 239 million.

Abbreviation : 1. United States Food and Drug Administration

2. Abbreviated New Drug Application