VIVUS announces FDA approval of Qsymia REMS Modification

theflyonthewall.com

VIVUS announced that the U.S. FDA has approved its amendment and modification to the Risk Evaluation and Mitigation Strategy for Qsymia (phentermine and topiramate extended-release) 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 FDA approval of the REMS modification, today we begin the process of increasing the availability of Qsymia, simplifying prescribing and dispensing and resolving the challenges associated with the mail-order-only system," said Peter Tam, president of VIVUS. Our goal over the next three months is to ensure availability of Qsymia in thousands of certified retail pharmacies nationwide. The REMS modification is a key accomplishment in removing a major barrier that has hindered the initial acceptance of Qsymia into everyday medical practice. We believe that retail access, along with ongoing improvements in reimbursement, will help to accelerate Qsymia awareness, trial and usage."

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