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news.Indevus Pharmaceuticals has overcome a regulatory hurdle in marketing its subcutaneous implant Vantas for the treatment of prostate cancer in several European countries.
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Following approval in Denmark in 2005, Massachusetts-based Indevus filed for Mutual Recognition Procedure (MRP) in the UK, Ireland, Germany, Spain and Italy. The Committee for Medicinal Products for Human Use has now finalized the referral, which allows for marketing authorization to occur in these countries.
Glenn Cooper, chairman and CEO of Indevus, said: “We plan to complete the process of obtaining final marketing authorization over the next few months and to begin MRP for the remaining countries in the European Union.”
Vantas is a soft and flexible 12-month hydrogel implant that provides histrelin, a luteinizing hormone-releasing hormone (LHRH) agonist, for the palliative treatment of advanced prostate cancer.
Additionally, Indevus announced that following the acquisition of Valera, the company has agreed to terminate a licensing and distribution agreement with Spepharm Holding, Valera’s European marketing partner for both Vantas and Supprelin LA.