Breckenridge Announces Final Approval of its ANDA for Pomalidomide Capsules (generic for Pomalyst®)
BERLIN, Conn., Nov. 13, 2020 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc., announced today that the U.S. Food and Drug Administration has approved Breckenridge's Abbreviated New Drug Application for Pomalidomide Capsules (generic for Pomalyst®).
Breckenridge has partnered with Natco Pharma Limited for the development and manufacture of this product. According to industry sales data, Pomalyst had annual sales of $957 million during the twelve months ending September 2020. Celgene, Breckenridge and Natco have settled the U.S. district court litigation with respect to this product.
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.
Natco Pharma Limited is 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.
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SOURCE Breckenridge Pharmaceutical, Inc.