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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]
Mazindol is used in short-term (i.e., a few weeks) treatment of obesity, in combination with a regimen of weight reduction based on caloric restriction, exercise, and behavior modification in people with a body mass index greater than 30, or in those with a body mass index greater than 27 in the presence of risk factors such as hypertension, diabetes, or hyperlipidemia.
Dexatrim further provides a disclaimer that no claims of efficacy and safety made by Dexatrim have been approved by the FDA. [1] Although available OTC, the active ingredients in Dexatrim products carry risk of side effects, adverse reactions and adverse drug interactions, particularly if used at high-recommended or higher-than-recommended ...
Products made by Nature Made, CeraVe and Neutrogena had the most No. 1 rankings.
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 ]
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