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  2. Anti-obesity medication - Wikipedia

    en.wikipedia.org/wiki/Anti-obesity_medication

    Originally available only by prescription, it was approved by the FDA for over-the-counter sale in February 2007. [32] In May 2010, the U.S. Food and Drug Administration (FDA) approved a revised label for Xenical to include new safety information about rare cases of severe liver injury that have been reported with the use of this medication. [33]

  3. Sibutramine - Wikipedia

    en.wikipedia.org/wiki/Sibutramine

    It was approved by the U.S. Food and Drug Administration (FDA) in November 1997 [24] for the treatment of obesity. Sibutramine is reported to be a prodrug to two active metabolites , desmethylsibutramine (M1; BTS-54354) and didesmethylsibutramine (M2; BTS-54505), with much greater potency as monoamine reuptake inhibitors.

  4. Orlistat - Wikipedia

    en.wikipedia.org/wiki/Orlistat

    On 23 January 2006, an FDA advisory panel voted 11 to 3 to recommend the approval of an OTC formulation of orlistat, to be sold under the brand name Alli by GlaxoSmithKline. [41] Approval was granted on 7 February 2007, [42] and Alli became the first weight loss drug officially sanctioned by the U.S. government for over-the-counter use. [43]

  5. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    A package insert from 1970, with Ovrette brand contraception pills A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications , the insert is technical , providing information for medical professionals about how to prescribe the drug.

  6. Regulation of food and dietary supplements by the U.S. Food ...

    en.wikipedia.org/wiki/Regulation_of_food_and...

    The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.

  7. First-in-class medication - Wikipedia

    en.wikipedia.org/wiki/First-in-class_medication

    A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. [1] While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category.

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