VIVUS, Inc. (VVUS) said Tuesday that the U.S. Food and Drug Administration has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy for Qsymia capsules CIV.
The amendment, submitted in October 2012, allows Qsymia to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies.
With the modification, the goals, commitments and components of the original Qsymia Risk Evaluation and Mitigation Strategy will remain in place, including a Medication Guide, patient brochure, voluntary healthcare provider training and other educational tools. These will continue to be available as part of the modified Qsymia Risk Evaluation and Mitigation Strategy program. Availability at certified retail pharmacies is expected within 90 days.
Qsymia is approved in the U.S. and is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol.
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