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Classified in: Health
Subjects: LAW, FDA

Breckenridge Announces Approval of its ANDA for Carfilzomib Intravenous Powder (generic for Kyprolis®)


BERLIN, Conn., June 16, 2021 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis®). This product was developed in collaboration with Natco Pharma Limited.  Breckenridge received final approval for the 10mg and 60mg strengths and tentative approval for the 30mg strength.   Onyx Therapeutics, Inc., Breckenridge and Natco have reached a Settlement Agreement and the District Court case against Breckenridge and Natco has been dismissed. By virtue of the settlement, Breckenridge has been granted a license permitting the launch of its generic carfilzomib product on a date that is held as confidential in 2027 or sooner depending on certain occurrences. The parties cannot make further comment as to the terms of the Settlement Agreement. According to industry sales data, Kyprolis generated annual sales of $711 million during the twelve months ending April 2021. 

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. 
www.bpirx.com

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. 
www.natcopharma.co.in

For further information, please contact: 
Breckenridge Pharmaceutical, Inc. 
Robert Gasparino, Associate Vice President ? Business Development 
Tel: 860-828-8140 
E-mail: rgasparino@bpirx.com

*All brand names and trademarks are the property of their respective owners.

SOURCE Breckenridge Pharmaceutical, Inc.


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