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In October 2011, Vivus resubmitted the NDA to the FDA with responses to the issues addressed in the CRL and the FDA accepted the NDA in November 2011. [10] [11] In September 2012, Qsymia became available on the US market. [12] In October 2012, approval was denied in the European Union, due to concerns regarding safety. [4] [5] [6]
Phentermine is used for a short period of time to promote weight loss, if exercise and calorie reduction are not sufficient, and in addition to exercise and calorie reduction. [ 5 ] [ 15 ] Phentermine is approved for up to 12 weeks of use and most weight loss occurs in the first weeks. [ 15 ]
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.
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