The United States Food and Drug Administration (www.fda.gov) has approved a supplemental New Drug Application (sNDA) for topical local anesthetic Pliaglis (lidocaine/tetracaine) 7%/7% Cream. Galderma Laboratories (www. galderma.com), a global pharmaceutical company that specialize in dermatology, will distribute Pliaglis, having licensed worldwide marketing rights from Nuvo Research Inc.
Pliaglis Cream uses Nuvo's proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. It is indicated for use on intact skin in adults to provide local analgesia for superficial aesthetic procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal.
“We are very pleased that the sNDA for Pliaglis has been approved by the FDA,” said Francois Fournier, president of U.S. and Canadian operations of Galderma Laboratories. “Pliaglis offers a pre-treatment solution and contributes to improving the patient experience of an aesthetic treatment.”