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Ahead of FDA decisions on one antibiotic, Nabriva plans resubmission of another

August 16, 2019 10:14 PM UTC

As it awaits FDA's decisions on twin NDAs for lefamulin, Nabriva said it plans to resubmit an NDA early next quarter for another one of its antibiotics following a complete response letter this year.

Nabriva Therapeutics plc (NASDAQ:NBRV) anticipates a decision from FDA by Monday on a pair of NDAs for IV and oral lefamulin, a semi-synthetic pleuromutilin antibiotic, to treat community-acquired bacterial pneumonia. The product represents a new antibacterial class that blocks protein synthesis by binding the peptidyl transferase center of bacterial ribosomes. ...

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