FDA Seeks More Information on Pliaglis

Thursday, April 19, 2012 | FDA Approval/Clearance


FDA's Complete Response Letter to Galderma Laboratories LP outlines additional information the FDA requires before it will approve the sNDA for Pliaglis, developer Nuvo Research, Inc. reports. The response is to the supplemental New Drug Application (sNDA) for the lidocaine and tetracaine 7%/7% topical cream. Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma. Nuvo says it will update the market when additional information is available. Pliaglis topical local anesthetic cream that uses Nuvo’s 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 dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal. Pliaglis was initially approved by the FDA in June 2006, but was voluntarily removed from the US market by Galderma in 2008 due to manufacturing issues at Galderma’s third-party contract manufacturer. The sNDA concerns a number of manufacturing issues including the transfer of manufacturing to Galderma.

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