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news.The European regulatory agencies have validated Nuvo Research's Pliaglis marketing authorization application (MAA) in the European Union (EU).
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The Pliaglis MAA was filed for the indication of producing local dermal anaesthesia on intact skin in adults prior to superficial dermatological procedures.
Previously, Nuvo Research has submitted the MAA in Germany as the Reference Member State and also with regulatory authorities in Austria, Belgium, Denmark, Greece, Spain, Finland, France, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Sweden and the UK as Concerned Member States.
Nuvo Research has licensed worldwide marketing rights for Pliaglis to Galderma Pharma.
Nuvo chairman and co-chief executive officer Dan Chicoine said validation of the MAA by regulatory agencies in Europe is an important step towards approval and launch of Pliaglis in key European markets.
"Based on the timing of the filing, Pliaglis remains on track for approval and launch in a number of EU countries in 2012," Chicoine said.