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FDA approves Qsymia REMS, grants access through retail pharmacies

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According to Vivus, manufacturer of combination phentermine/topiramate, the FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy. The amendment, submitted in October 2012, allows phentermine and topiramate extended-release capsules CIV to be dispensed through certified retail pharmacies, in addition to the existing network of certified mail-order pharmacies, according to a press release.

The original phentermine/topiramate extended-release (Qysmia) REMS will remain in place and will now include a Medication Guide, patient brochure, voluntary health care provider training and other educational tools. Availability at certified retail pharmacies is expected within 90 days, according to the press release. Vivus advises health care providers and patients to use the current certified mail-order network until further notice.