Everolimus / Zortress Approval 06-01-2021

[ June 01, 2021 ]

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



Berlin, Connecticut, June 1, 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 Zortress®). This product was developed in collaboration with Natco Pharma Limited. According to industry sales data, Zortress and its therapeutic equivalents generated annual sales of $162 million during the twelve months ending March 2021.  Breckenridge plans to launch Everolimus Tablets in 0.25mg, 0.5mg and 0.75mg strengths during the third quarter of 2021 in a blister card packaging configuration.


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 quality of life 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.


For further information, please contact:

Breckenridge Pharmaceutical, Inc.

Robert Gasparino, Associate Vice President – Business Development

Tel: 860-828-8140



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