Restylane Gets FDA Nod for Lip Augmentation
Medicis Pharmaceutical Corp is proud to announce that the FDA has approved the use of the Restylane hyaluronic acid dermal filler to incorporate lip augmentation. Restylane was formerly approved to treat moderate to severe facial wrinkles and folds, such as the lines from the nose to the nasolabial folds. The new label will now include an indication for submucosal implantation for lip augmentation in patients over the age of 21.
Chairman and CEO of Medicis Jonah Shacknai, is pleased with FDA’s decision to expand the Restylane label to include lip augmentation. Restylane is now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. 180 patients were evaluated during the study for six months. Safety was measured by adverse events reported throughout the study and patient diaries kept for two weeks after lip augmentation treatment.
Furthermore, Medicis designed nine lip safety assessments which were preformed at various intervals throughout the six month case study, including 72 hours after each treatment and again at two weeks after each treatment.
Mark A Bishara, M.D., P.A. Medical Director
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