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.
For more information call (888) 998-4887 or visit www.qsymia.com.