Sanofi-Aventis and Novalar Pharmaceuticals announced that the Marketing Authorization Application (MAA) for OraVerse has been accepted for review by the regulatory agencies of the U.K., Germany, Italy, France, and Spain.
OraVerse, a local anesthesia reversal agent, has U.S. FDA clearance and is sold by Novalar directly 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 CEO 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."
In March 2010, Novalar and Sanofi-Aventis announced an exclusive license and distribution agreement for OraVerse. Under the terms of the agreement, Sanofi-Aventis will be responsible for the launch of OraVerse in Germany upon approval and retains options to extend the license to all European countries. Novalar is eligible for an additional milestone payment upon approval, royalties on product sales in the territory and prede
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