The Food and Drug Administration (FDA or Agency) has determined that PONDIMIN (fenfluramine hydrochloride (HCl)) tablets, 20 milligrams (mg) and 60 mg, and PONDEREX (fenfluramine HCl) capsules, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for fenfluramine HCl tablets, 20 mg or 60 mg, or fenfluramine HCl capsules, 20 mg.
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Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that PONDIMIN (fenfluramine hydrochloride (HCl)) tablets, 20 milligrams (mg) and 60 mg, and PONDEREX (fenfluramin...
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80 FR 58490
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“Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for Reasons of Safety or Effectiveness,” thefederalregister.org (September 29, 2015), https://thefederalregister.org/documents/2015-24619/determination-that-pondimin-fenfluramine-hydrochloride-tablets-20-milligrams-and-60-milligrams-and-ponderex-fenfluramine.