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.
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