Nuvo Research Inc. and Galderma Laboratories, L.P., the U.S. affiliate of Galderma Pharma, S.A., today announced that the FDA has approved a supplemental New Drug Application (sNDA) for Pliaglis (lidocaine/tetracaine) 7%/7% Cream. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology.
Pliaglis is a topical local anesthetic cream that uses Nuvo’s proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. Pliaglis 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.” “This is yet another significant milestone for Nuvo this year,” said Dr. Bradley Galer, President of Nuvo’s Pain Group. “Pliaglis is an important part of Nuvo’s expanded topical pain product portfolio.”