Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)
The Agency is currently planning to hold an advisory committee meeting to discuss this application.
- The Agency is currently planning to hold an advisory committee meeting to discuss this application.
- SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
- Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options.
- Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.