Vivus, Inc. announced that the FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia (phentermine and topiramate) extended-release capsules. Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of ≥30kg/m2 or ≥27kg/m2 in the presence of at least one weight related co-morbidity (eg, hypertension, type 2 diabetes, or dyslipidemia).

This amendment allows Qsymia to be dispensed through certified retail pharmacies in addition to the existing certified mail-order pharmacies.  As part of the modified Qsymia REMS program, a Medication Guide, a patient brochure, voluntary healthcare provider training and other educational tools will continue to be available.

Qsymia is expected be to be available in certified retail pharmacies within 90 days.

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