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Paratek submits applications to US FDA for broad-spectrum antibiotic

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.