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news.Apricus Biosciences has secured national phase approval from the Ministry of Health of Luxembourg for Vitaros, a topical on-demand treatment for erectile dysfunction (ED).
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After the broad approval by European health authorities in June 2013, the company has received a total of nine national phase approvals for Vitaros, including Luxembourg, Belgium, France, Germany, Ireland, Italy, the Netherlands, Sweden and the UK.
The company is currently in partnership with Hexal, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz), for the commercialization of Vitaros in several European countries, including Luxembourg.
Apricus chief executive officer Richard Pascoe said the company is happy with the continued progress it has made, together with its partners, towards obtaining Vitaros national phase approvals in Europe.
"We continue to support our partners as they prepare to launch Vitaros in their respective territories later this year," Pascoe said.
"Importantly, we have successfully manufactured commercial product, which has met all required release and shelf-life specifications for Europe, and we look forward to the planned launch of Vitaros throughout this year by our partners."
The company got marketing application approval in June 2013 for Vitaros through the European Decentralized Procedure (DCP), under which it has filed its application for marketing approval designating the Netherlands as the Reference Member State (RMS) on behalf of nine other European Concerned Member States (CMS) participating in the procedure.
Market launch of Vitaros is scheduled throughout 2014 and is preparation by the company’s existing commercialization partners. The company’s current commercialization partners are preparing for the launch of Vitaros in their respective territories throughout 2014.