Posted by Michael Wonder on 04 Jan 2018
Paratek provides update on pipeline progress
3 January 2018 - Rolling NDA submission underway for omadacycline in pneumonia and skin infections.
Paratek Pharmaceuticals today announced recent progress across its product pipeline. Paratek has initiated the rolling submission of a new drug application to the U.S. FDA for the indications of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) and is on track to submit the final components during the first quarter of 2018. Rolling submission allows completed portions of an NDA to be reviewed by the FDA on an ongoing basis. The FDA had previously granted omadacycline qualified infectious disease product designation and fast track designation, which provides for a priority review of the application, once accepted.
