Briefs: Added use for Theravance's Vibativ; approval sought for ViiV dolutegravir; FDA accepts Pfizer sNDA for Xeljanz
USA-based Theravance (Nasdaq: THRX) says that the US Food and Drug Administration has approved the firm’s Vibativ (telavancin) for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable.
In 2009, Vibativ was approved in the USA for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains (The Pharma Letter September 14, 2009).
ViiV Healthcare expects FDA decision on HIV drug dolutegravir in August
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