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# FDA Approves Theravance sNDA for Vibativ
- URL: https://www.fdaweb.com/fda-approves-theravance-snda-for-vibativ/
- Published: 2016-05-09T12:00:00.000Z
- Updated: 2026-09-14T21:00:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135607

> FDA has approved a Theravance Biopharma supplemental NDA for Vibativ (telavancin) to expand the antibiotic’s label to include data describing the treatment of patients with concurrent *Staphylococcus aureus* bacteremia in both currently approved indications. Vibativ is approved in the U.S. for treating adult patients with hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible isolates of *S. aureus* when alternative treatments are not suitable. In addition, it is approved for treating adult patients with complicated skin & skin structure infections caused by susceptible isolates of Gram-positive bacteria, including *S. aureus*, both methicillin-susceptible and methicillin-resistant strains.  
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> The sNDA was based on combined data from Theravance’s previously conducted pivotal trials, ATLAS I and II and ATTAIN I and II. The trials were large, multi-center, multinational, double-blind, randomized Phase 3 clinical studies enrolling and treating 3,370 adult patients, including a portion of patients with concurrent bacteremia, according to the company.