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Paratek's Omadacycline Get US Panel OK, But CABP Mortality Remains Concern

 
• By Derrick Gingery

Most FDA advisory committee members say potential mortality issue seen in community acquired bacterial pneumonia patients can be addressed postmarket.

Dart arrow hitting in the target center of dartboard using as background Target business, achieve and victory,success concept.

A potential increase in mortality associated with Paratek Pharmaceuticals Inc.'s omadacycline in community-acquired bacterial pneumonia concerned many advisory committee members, but it was not enough to push them to vote that product safety had not been demonstrated.

Paratek is seeking approval for the tetracycline derivative in CABP as well as acute bacterial skin and skin structure infections (ABSSSI). The Antimicrobial Drugs Advisory Committee voted overwhelmingly Aug

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