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Canada : Nuvo And Galderma Announce Fda Approval Of Pliaglis.

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and Galderma Laboratories, L.P., the U.S. affiliate of Galderma Pharma, S.A. (Galderma), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for PliaglisA (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.

About Nuvo Research Inc.: Nuvo Research is a publicly traded, Canadian specialty pharmaceutical company, headquartered in Mississauga, Ontario. The Company is building a portfolio of products for the treatment of pain through internal research and development and by in-licensing and acquisition. The Company s product portfolio includes PennsaidA, Pliaglis and SyneraA. Pennsaid, a topical nonsteroidal anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of osteoarthritis of the knee(s). Pennsaid is sold in the United States by Mallinckrodt Inc., a Covidien company, in Canada by Paladin Labs Inc. and in several European countries. Pliaglis is a topical local anesthetic cream which provides topical local analgesia for superficial dermatological procedures. The Company has licensed worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global specialty pharmaceutical company specialized in dermatology. Synera is a topical patch that combines lidocaine, tetracaine and heat, approved in the United States to provide local dermal analgesia for superficial venous access and superficial dermatological procedures and in Europe, for surface anaesthesia of normal intact skin. Nuvo currently markets Synera in the United States and its licensing partner, Eurocept International B.V., has initiated a pan-European launch of Synera (under the name RapydanA) in several European countries.

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Publication:Mena Report
Date:Oct 22, 2012
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