Nuvo Research Inc. (NRI.TO) announced Wednesday that the FDA has denied approval for topical local anesthetic cream Pliaglis. Originally developed by Zars Pharma Inc., Pliaglis came into Nuvo's fold when Zars was acquired by Nuvo last May.
Pliaglis was approved by the FDA in June 2006 to provide topical local analgesia for superficial dermatological procedures, such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing and laser-assisted tattoo removal.
In February 2007, Zars Pharma granted Swiss firm Galderma Pharma S.A., the promotion and distribution rights of Pliaglis in the U.S and Canada. The following year - in March 2008, Galderma was granted worldwide marketing rights to Pliaglis.
Pliaglis was voluntarily removed from the U.S. market by Galderma in 2008, due to manufacturing issues at Galderma's third-party contract manufacturer. Galderma has since transferred Pliaglis manufacturing to its own facilities.
Having resolved the manufacturing issues, Galderma filed a supplemental New Drug Application for Pliaglis, which was accepted for review by the FDA earlier this year. However, the anesthetic has failed to cross the regulatory hurdle with the FDA issuing a Complete Response Letter for Pliaglis.
Nuvo said it is working with Galderma to fully understand the FDA's requirements as outlined in the Complete Response Letter and update the market when additional information is available.
NRI.TO is down 16% at C$0.10.
by RTT Staff Writer
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