Breckenridge Announces Approval of its ANDA for Cabazitaxel Intravenous Solution (generic for Jevtana Kit®)
01 Aug 2022
BERLIN, Conn., Aug. 1, 2022 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Cabazitaxel Intravenous Powder (generic for Jevtana Kit®). This product was developed in collaboration with Natco Pharma Limited. Breckenridge received final approval for the 60mg/1.5mL (40mg/mL) strength. Breckenridge and Natco are unable to make further comment regarding the launch date for the product, as that is confidential and cannot be disclosed at this time. According to industry sales data, Jevtana Kit generated annual sales of $303 million during the twelve months ending May 2022.
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 strive to impact the health 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:
Robert Gasparino, Associate Vice President – Business Development
Tel: 860-828-8140
E-mail: [email protected]
*All brand names and trademarks are the property of their respective owners.
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