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Published on FierceBiotech (http://www.fiercebiotech.com)

FDA denies second approval for Theravance drug

By john
Created Nov 30 2009 - 10:58am

Theravance said last Friday that the FDA had declined to provide an approval to use Telavancin for the treatment of nosocomial pneumonia, but hastened to add that it had already completed the extra analysis work that the FDA is seeking. Nevertheless, the developer adds that any approval will be delayed into 2010. Telavancin is already approved for skin infections. Report [1]


Source URL:
http://www.fiercebiotech.com/story/fda-denies-second-approval-theravance-drug/2009-11-30