Generic Name: lidocaine and tetracaine cream
Date of Approval: July 6, 2006
Company: ZARS Pharma
Treatment for: Topical Local Anesthesia
The U.S. Food and Drug Administration (FDA) has approved a topical local anesthetic peel developed under the name of S-Caine Peel (Lidocaine and Tetracaine) 7%/7% Cream.
The approved product will be used to locally anesthetize intact skin before various superficial dermatological procedures such as dermal filler procedures, pulsed dye laser therapy, facial laser resurfacing, and laser- assisted tattoo removal. The product is indicated for use in adults.
The Lidocaine and Tetracaine 7%/7% Cream is a topical local anesthetic cream that forms a pliable peel on the skin when exposed to air. The approved product is applied for 20-30 minutes prior to procedures such as dermal filler injections or facial laser ablation, and for 60 minutes for procedures such as laser-assisted tattoo removal.
Robert Lippert, President and Chief Executive Office of ZARS Pharma, stated, "We are thrilled with the FDA approval. This product will provide physicians with a new option in reducing patients' pain associated with common cosmetic and aesthetic procedures. I am also very proud of the ZARS organization since this approval represents the second NDA approval in the last 12 months."
In clinical trials, the most common side effects were local skin reactions, such as erythema, blanching and edema. The Lidocaine and Tetracaine 7%/7% Cream should not be used for a duration longer than recommended, and is contraindicated in patients with a known history of sensitivity to lidocaine, tetracaine, or local anesthetics of the amide or ester type. The FDA has not approved a proprietary name yet; a proprietary name will have to receive FDA approval prior to the U.S. launch of the product.