Posted by Michael Wonder on 06 Feb 2018
Paratek completes submission of new drug applications to U.S. FDA for oral and intravenous omadacycline for pneumonia and skin infections
5 February 2018 - Paratek Pharmaceuticals announced today that on February 2, 2018, it completed the submission of two new drug applications to the U.S. FDA for the company’s once-daily oral and IV formulations of its broad-spectrum investigational antibiotic, omadacycline.
Omadacycline is the first in a new class of tetracycline antibiotics known as aminomethylcyclines. Paratek is seeking FDA approval for omadacycline for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections, based on the results of three successful Phase 3 pivotal studies.
The FDA has previously granted omadacycline both qualified infectious disease product and fast track designation for these indications, which provide for a priority review of the applications, once accepted.
