Acting Assistant Attorney General Stuart F. Delery announced that the Department of Justice (DOJ), on behalf of the FDA, has filed suit in the U.S. District Court for the Western District of Louisiana against Sage Pharmaceuticals, its president, Jivn-Ren Chen, MD, and its director of corporate quality, Charles L. Thomas, all of Shreveport, La. According to the complaint, the defendants violated the Federal Food, Drug, and Cosmetic Act (FDCA) by manufacturing and distributing unapproved and misbranded drug products.
   "Today's action furthers the FDA's mission of ensuring that all drugs sold to the public are safe and effective, and those companies that undermine this mission will be held accountable," said Mr. Delery.
   This is the second injunctive case that the government has brought against Sage alleging the distribution of unapproved new drugs. In 2000, the government obtained an injunction against the company banning the manufacture and distribution of two unapproved new drugs. Since then, FDA inspections have allegedly revealed that the defendants continue to manufacture and distribute other drug product—including prescription pain relievers, over-the-counter (OTC) cough and cold remedies and OTC wound cleansers—without first obtaining the requisite FDA approvals.
   "As a result, the defendants' products are unapproved new drugs and misbranded drugs under the FDCA, and potentially unsafe and ineffective," according to a press statement from the DOJ.
   The release stated, "despite numerous warnings from [the] FDA, the defendants have failed to bring their operations into compliance with the law." The DOJ announced it will seek a permanent injunction requiring the defendants to cease all receiving, processing, manufacturing, preparing, packaging, labeling, holding and distributing activities until they comply with applicable FDA regulations.
The FDA referred this matter to the DOJ. The Consumer Protection Branch of the DOJ's Civil Division together with the U.S. Attorney's Office for the Western District of Louisiana brought this case on behalf of the United States.
—Based on a press release from the Department of Justice

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