Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Imatinib Mesylate Tablets, generic for Gleevec® Tablets by Novartis.
BOCA RATON, Fla., /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Imatinib Mesylate Tablets, generic for Gleevec® Tablets by Novartis. Breckenridge’s Imatinib Mesylate Tablets product was developed in collaboration with Stason Pharmaceuticals Inc. and will be commercially manufactured by Stason in 100mg and 400mg product strengths. Breckenridge plans to launch the product in the near future. The product generated annual sales of approximately $654.8 million over the year ending December 31, 2018, according to industry sales data. About Breckenridge: About Stason: Gleevec® is a registered trademark of Novartis. View original content:http://www.prnewswire.com/news-releases/breckenridge-announces-final-approval-of-its-anda-for-imatinib-mesylate-tablets-rld-gleevec-300805966.html SOURCE Breckenridge Pharmaceutical, Inc. |