Tag Archive: Drug

Mar 27

FDA Warns of Marketing Cosmetics with Drug Claims

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) governs the regulation of drugs and cosmetic products. The Act defines a cosmetic, in part, …

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Oct 22

FDA Approval Required for Company Enjoined from Marketing Products

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As we previously reported, Ascend had been targeted in connection with the marketing and sale of …

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Jul 12

FDA Seeks Injunction against Company for Misbranding Drug Products

On June 25, 2014, the U.S. Department of Justice (“DOJ”), in response to a request made by the U.S. Food and Drug Administration (“FDA”), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company’s president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District …

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May 28

FDA Seizes Topical Creams Deemed Drugs

On May 16, 2014, the U.S. Food and Drug Administration (“FDA”), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The products seized by the …

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Aug 29

FDA Approves First Drug Specifically Formulated to Treat Pediatric Tumors

On August 29, 2012, the U.S. Food and Drug Administration (“FDA”) announced the Agency’s approval of a new drug formulated specifically to treat children with a rare type of brain tumor, known as subependymal giant cell astrocytoma (SEGA). Manufactured by Novartis, Afinitor Disperz is a new dosage form of the existing anti-cancer drug Afinitor. While …

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May 20

FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of …

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