Restylane获FDA批准丰唇适应症
据外媒报道（Restylane Receives Indication for Lip Augmentation, 10/12/2011），Restylane已获得美国FDA批准新增适应症：丰唇，成为获得FDA批准该适应症的首个和目前唯一一个透明质酸填充剂产品。

Restylane透明质酸填充剂于2005年首次获得美国FDA批准适应症（中至深层真皮注射矫治中至重度面部皱纹），此后丰唇适应症在市场上一直作为标注外使用。

今年4月，FDA专家组以6:0(1人弃权)投票赞成：Restylane用于丰唇总体上安全、有效，对患者利益大于风险（详见相关报道）；同时，专家组也指出，厂商提交数据缺乏男性和深色皮肤人种的数据。

相关报道：FDA专家组：Restylane注射丰唇安全有效

First and Only Hyaluronic Acid Dermal Filler Approved for Lips

SCOTTSDALE, Ariz., Oct. 11, 2011 -- Medicis (NYSE:MRX) 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® 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.转载请注明出自论坛@医学美容时讯 http://bbs.aesthetictimes.com/bbs/,本贴地址:http://bbs.aesthetictimes.com/bbs/viewthread.php?tid=10933