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10/24/2011
Restylane Gets FDA Nod for Lip Augmentation
Medicis Pharmaceutical Corp announced that the FDA has approved its premarket approval application (PMA) supplement to expand the approved use of the Restylane hyaluronic acid dermal filler to include lip augmentation
Restylane Gets FDA Nod for Lip Augmentation

Medicis Pharmaceutical Corp announced that the FDA has approved its premarket approval application (PMA) supplement to expand the approved use of the Restylane hyaluronic acid dermal filler to include lip augmentation.

Restylane was previously 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.

"We are pleased with the FDA's decision to expand the Restylane label to include lip augmentation," says Jonah Shacknai, Chairman and CEO of Medicis. "This marks another significant milestone for Restylane, now the first and only hyaluronic acid dermal filler approved in the United States for lip augmentation. We were very encouraged by the compelling data from the robust pivotal clinical study, showing effectiveness for up to six months, with a clear majority of eligible subjects opting for retreatment at six months. We believe physicians and their patients will appreciate the unique gel particle structure of Restylane and its ability to create fullness in the lips for up to six months."

A randomized, evaluator-blinded, no-treatment-as-a-control, multicenter study enrolled 180 patients to evaluate the safety and effectiveness of Restylane for lip augmentation in both the upper and lower lip. Subjects randomized to Restylane treatment at the beginning of the study were retreated at six months, and subjects randomized to no treatment received their first Restylane treatment at six months.

Safety was measured by adverse events reported throughout the study and patient diaries kept for two weeks after lip augmentation treatment. Additionally, Medicis designed nine lip safety assessments which were performed at various intervals throughout the 7-month study, including 72 hours after each treatment and again at 2 weeks after each treatment.
Photo Release -- FDA Approves Lip Indication for Medicis' Restylane(R)
First and Only Hyaluronic Acid Dermal Filler Approved for Lips


SCOTTSDALE, Ariz., Oct 11, 2011 (GlobeNewswire via COMTEX) -- Medicis /quotes/zigman/156404/quotes/nls/mrx MRX -0.23% today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval application (PMA) supplement to expand the approved use of RESTYLANE(R) Injectable Gel, a hyaluronic acid dermal filler, to include lip augmentation. RESTYLANE was previously 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). The new label will now include an indication for submucosal implantation for lip augmentation in patients over the age of 21. The RESTYLANE package insert will be amended to include the new indication, along with results from the clinical trials for lip augmentation. The Company anticipates using this information in its training and promotional activities.

http://www.plasticsurgerypractice.com/eReport/2011...

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