FDA, yeni lidokain formülasyonuna onay verdi.
FDA Approves New Lidocaine Formulation for Topical Pain Relief sNDA
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for lidocaine/tetracaine 7%/7% cream (Pliaglis, Nuvo Research Inc and Galderma).
Pliaglis was initially approved by the FDA in June 2006 but was voluntarily removed from the US market by Galderma in 2008 because of manufacturing issues at Galderma’s contract manufacturer.
Previously, on April 18, 2012, a complete response letter was issued, in which the FDA requested additional information before approving the sNDA. The current sNDA concerns several manufacturing issues, including the transfer of manufacturing to Galderma.
According to the manufacturer, the topical local anesthetic cream uses a proprietary phase-changing technology to form a pliable peel on the skin when exposed to air. The cream 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.
In clinical trials, lidocaine/tetracaine 7%/7% cream was associated with local adverse events, including erythema (47%), skin discoloration (16%), and edema (14%). Most of these events were transient. The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of less than 1%.
Nuvo has licensed worldwide marketing rights for Pliaglis to Galderma, a global pharmaceutical company specialized in dermatology.