FDA Panel Recommends Lip Indication for Medicis' RESTYLANE (MRX)

Medicis

today announced that the U.S. Food and Drug Administration's General and Plastic Surgery Devices Advisory Panel (the Panel) has recommended with a 6-0 vote (1 abstaining) that FDA expand the approved use of RESTYLANE® Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE is currently approved to treat moderate to severe facial wrinkles and folds, such as the lines from the nose to the corners of the mouth (nasolabial folds).