An advisory panel on plastic surgery devices voted to expand approved indications for the popular wrinkle filler, which could allow Restylane to be marketed for lip augmentation purposes.
Restylane is already approved for non-surgical correction of facial wrinkles – typically the nasolabial folds on each side of the mouth. The filler was one of the first hyaluronic acid based products to receive FDA approval (in 2004). Expansion of its approved indications would make Restylane the first HA filler approved for lip augmentation.
Jonah Shacknai, CEO and Chairman of Medicis, says his company is “pleased with the panel’s recommendation,” and they believe the recommendation “reflects confidence in the robust clinical data provided by Medicis.”
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