The U.S. Food and Drug Administration received two new drug applications for Paratek Pharmaceuticals Inc.'s oral and IV formulations of its broad-spectrum investigational antibiotic, omadacycline.
Paratek is seeking FDA approval for omadacycline to treat community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
Omadacycline is the first in a new class of tetracycline antibiotics known as aminomethylcyclines.
Paratek said the applications are based on the results of three successful phase 3 studies.
The FDA has previously granted omadacycline both qualified infectious disease product and fast-track designation as a treatment for these diseases, which provide for a priority review of the applications, once accepted.
