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06/20/2013 05:26 PM EDT
Acting Assistant Attorney General Stuart F. Delery announced today that the Department of Justice, on behalf of the Food and Drug Administration (FDA), has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, Inc. (Sage), its president Dr. Jivn-Ren Chen, and its Director of Corporate Quality, Charles L. Thomas, all of Shreveport, Louisiana. According to the Complaint, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing unapproved and misbranded drug products. Under the FDCA, before a company can sell a new drug product to consumers, it must submit and receive approval of a new drug application from the FDA. The purpose of this approval process is to ensure that drugs manufactured and distributed to consumers are safe and effective for their intended uses. Furthermore, the FDA requires all drug labeling to have adequate directions for use.
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