Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Teriflunomide Tablets (generic for Aubagio®).
BERLIN, Conn., Sept. 29, 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 Teriflunomide Tablets (generic for Aubagio®). This product was developed in collaboration with PharmaZell GmbH, Germany. Breckenridge received final approval for the 7mg and 14mg strengths. Sanofi Aventis LLC and Breckenridge have entered into a Settlement Agreement that permits Breckenridge to launch its generic teriflunomide product on March 12, 2023. According to industry sales data, Aubagio generated annual sales of approximately $1.9 billion during the twelve months ending July 2021. About Breckenridge: About Pharmazell: For further information, please contact: *All brand names and trademarks are the property of their respective owners. View original content to download multimedia:https://www.prnewswire.com/news-releases/breckenridge-announces-approval-of-its-anda-for-teriflunomide-tablets-generic-for-aubagio-301387953.html SOURCE Breckenridge Pharmaceutical, Inc. |