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Monday, 11/30/2009 9:31:54 AM

Monday, November 30, 2009 9:31:54 AM

Post# of 62
7:01AM Theravance announces that EMEA has completed the validation phase for the Telavancin MAA for the treatment of nosocomial pneumonia and complicated skin and soft tissue infections (THRX) 13.13 : Co announces the European Medicines Agency (EMEA) has completed the validation phase for the Marketing Authorization Application for telavancin, a bactericidal, once-daily injectable lipoglycopeptide antibiotic, for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, and complicated skin and soft tissue infections in adults. Astellas Pharma Europe B.V., a European affiliate of Astellas Pharma Inc. submitted the MAA in October 2009 under the Centralized Procedure and applied for marketing authorization for telavancin in the Member States of the European Union, plus Iceland, Liechtenstein and Norway. The successful completion of the validation phase for a MAA signifies that the submission is administratively complete and that EMEA's scientific review process has begun.


surf's up......crikey



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