Qnexa REMS Should Deter Off-Label Use Of Components, But Not Place Undue Burden
The Endocrinologic and Metabolic Drugs Advisory Committee voted 20-2 in favor of approving the combination of phentermine and topiramate for weight loss during its second review of Vivus’ application.
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A Risk Evaluation and Mitigation Strategy for Qsymia includes prescriber education about the risk of birth defects and limits dispensing to specially certified pharmacies
With a July 17 user fee date, Vivus’ obesity drug Qnexa could beat Arena Pharmaceuticals’ Belviq to the marketplace as lorcaserin awaits controlled substance scheduling by the Drug Enforcement Agency.
FDA did not ask its Antiviral Drugs Advisory Committee whether Gilead’s proposed REMS for pre-exposure prophylaxis should include restricted distribution, but it still got an earful on the subject from some vocal panel members, who said prescribing should be limited only to individuals with documentation of a negative HIV test. Agency staff, however, said such an approach was impractical due to Truvada’s unrestricted availability for HIV treatment.