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Theravance telavancin NDA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Theravance submits telavancin for treatment of complicated skin and skin structure infections. The South San Francisco biopharmaceutical company is requesting a priority review for the injectable lipoglycopeptide antibiotic, giving it an estimated user fee date of June 7. The NDA is based on the firm's ATLAS I and ATLAS II trials, which Theravance says were "the largest clinical program ever" in CSSSIs. The company is collaborating with Astellas on development and commercialization of telavancin...

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