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FDA panel says Allergan's Juvederm data supports product effectiveness

An FDA panel said in briefing documents ahead of a May 2 meeting regarding Allergan's facial filler, "Juvederm Voluma XC met the pre-specified primary endpoint, and the secondary endpoints support product effectiveness. FDA concludes the balance of the evidence indicates that Juvéderm Voluma XC is effective in correcting volume deficit in the mid-face at the 6-month primary effectiveness time point...The FDA review team has made the recommendation that if Juvederm Voluma XC is approved, a post-approval study should be required as a condition of approval. Through premarket review of the PMA, FDA has identified safety of the device after repeat treatment as a potential postmarket concern and recommends that a PAS be conducted to assess the long-term performance of Juvéderm following retreatment."