SAN DIEGO, July 14 /PRNewswire/ -- Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals, Inc. today announced that the Marketing Authorization Application (MAA) for OraVerse has been accepted for review by the regulatory agencies of the United Kingdom (UK), Germany, Italy, France and Spain. OraVerse is the first and only local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. OraVerse is approved for use in the U.S. by the Food and Drug Administration and sold by Novalar direct to U.S. dentists.
"Expansion of OraVerse into Europe represents a significant near-term opportunity for Novalar, and it is our goal to obtain marketing approval by mid-2011," said Donna Janson, President and Chief Executive Officer of Novalar. "Dentists in the five key countries included in the dossier utilize approximately 270 million cartridges of local dental anesthetic each year, which is about 75% of the total local anesthetic usage in all of Europe. Germany is by far the largest single market for local anesthetic usage and Sanofi-Aventis leads the market with its anesthetic Ultracain®."
The proposed indication for OraVerse in Europe is comparable to the product's approved indication in the United States. The application will follow the Decentralized Procedure for obtaining marketing authorization in select European countries, with the UK as the Reference Member State (RMS) and
SOURCE Novalar Pharmaceuticals, Inc.
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