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12/19/2003

Wrinkle Treatment Gains FDA Approval

Kate Traynor

The Food and Drug Administration last week approved the marketing of Restylane, an injectable hyaluronic acid gel, for the treatment of moderate to severe wrinkles and folds around the nose and mouth.

Medicis Pharmaceutical Corp. will market the Swedish-manufactured product in the United States. The company announced that the gel-filled device will be available by mid-February from McKesson Corp., the product's sole U.S. distributor.

According to the device's FDA-approved labeling, Restylane is supplied as a disposable glass syringe containing sterile gel at a concentration of 20 mg of hyaluronic acid per milliliter. The volume of product is not specified in the labeling. A gamma-irradiated, 30-gauge, 1.5-inch needle is supplied with the product, along with instructions for assembling the device and administering the product.

No more than 1.5 mL of gel should be injected into each wrinkle, according to the labeling.

Restylane is contraindicated in patients with a history of anaphylaxis or multiple severe allergies or allergic reactions to gram-positive bacteria; the hyaluronic acid in the gel is generated by a Streptococcus species. Restylane must not be used for breast augmentation or injected into a blood vessel, bone, tendon, or ligament. Injection of the product into a blood vessel can occlude the vessel and cause an infarction or embolism.

The most common adverse events reported after the injection of the gel were transient, mild to moderate redness and swelling at the injection site.