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Paratek broad-spectrum antibiotic gets US FDA committee's nod

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Paratek broad-spectrum antibiotic gets US FDA committee's nod

Paratek Pharmaceuticals Inc. said a committee of the U.S. Food and Drug Administration voted in favor of its antibiotic omadacycline to treat bacterial pneumonia and skin infections.

According to an Aug. 8 news release, the Antimicrobials Drug Advisory Committee voted 17-1 in favor of omadacycline to treat acute bacterial skin and skin structure infections, or ABSSSI, and voted 14-4 to treat community-acquired bacterial pneumonia, or CABP.

The committee's recommendations come on the heels of another FDA decision that noted that omadacycline was not inferior to other treatments.

Previously, the FDA granted a priority review status to Paratek's two new drug applications for omadacycline, for which approval is being sought in oral and intravenous formulations.

Boston-based Paratek said the recommendations were based on positive data from three completed phase 3 trials evaluating the safety and efficacy of the antibiotic.

The FDA is not bound by the committee's recommendation but takes its input into consideration when approving a drug.

Paratek said the FDA is expected to make a decision on the company's applications for the drug by early October.