Tag: VIVUS

VIVUS

Regulatory/FDA

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

June 19, 2019 – The FDA’s Office of Prescription Drug Promotion (OPDP) has cited VIVUS Inc. for making false or misleading claims about the efficacy of and risks associated with Qsymia capsules, which are intended to be an adjunct treatment for obesity with a reduced-calorie diet and increased exercise, but allegedly were promoted as being […]

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