The United States Food & Drug Administration (www.fda.gov) has accepted a supplemental New Drug Application (sNDA) for review for topical local anesthetic cream Pliaglis. The anesthetic—owned by Nuvo Research and distributed in the U.S. exclusively by Galderma Laboratories, originally received FDA approval in June 2006. Galderma voluntarily pulled the product from the market in 2008, due to manufacturing issues that occurred at a third-party manufacturing facility. Galderma has since transferred Pliaglis manufacturing to its own facility and has filed the sNDA because the company believes it has addressed all manufacturing issues. Pliaglis is intended for use prior to dermal filler injections, pulsed dye laser, resurfacing and laser-assisted tattoo removal procedure. Galderma plans to launch the marketing and sale of the product in the second half of 2012.
Pliaglis Topical Anesthetic Heads Back To Market
Mar 2nd, 2012
