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Antimicrobial Drugs Advisory Committee

On Wednesday, August 8,2018 the Antimicrobial Drugs Advisory Committee (AMDAC) discussed new drug applications (NDAs) for omadacycline tablets and injection, sponsored by Paratek Pharmaceuticals, Inc. (Paratek), for the proposed indications for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

A majority of the Committee, 17 of 18 members, voted that Paratek has provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

A majority of the Committee, 14 of 18 members, voted that Paratek has also provided evidence of the safety and effectiveness of omadacycline for the treatment of community acquired bacterial pneumonia (CABP).

Earlier Event: August 7
Antimicrobial Drugs Advisory Committee
Later Event: September 12
Pharmacy Compounding Advisory Committee