Breckenridge Announces Final Approval of its ANDA for Everolimus Tablets (generic for AfinitorĀ®)

[ March 08, 2021 ]

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Everolimus Tablets (generic for Afinitor®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Afinitor and its therapeutic equivalents generated annual sales of $712 million during the twelve months ending December 2020.  Breckenridge plans to launch Everolimus Tablets in 2.5mg, 5mg and 7.5mg strengths during the second quarter of 2021 in a blister card packaging configuration. Breckenridge’s launch of the product’s 10mg strength is based on terms that are presently confidential and will be announced at a later date. 

 About Breckenridge:

Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical (Osaka, Japan), partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients.  With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and lives of the patients we and our customers serve.

About Natco:

Natco Pharma Limited is a global generic pharmaceutical research, development, manufacturing and marketing company. The company was established in 1981 in India. Natco supplies pharmaceutical products to over 50 countries across the globe, including the United States. Natco focuses on the development and manufacturing of oncology and other specialty pharmaceuticals.