Nabriva Therapeutics announced the submission of two new drug applications, or NDAs, to the FDA for the oral and intravenous, or IV, formulations of lefamulin semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia, or CABP. Both formulations of lefamulin were granted qualified infectious disease product and fast track designation by the FDA, enabling potential priority review of the NDAs by the FDA. Nabriva Therapeutics plans to submit a marketing authorization application for lefamulin in Europe in Q1 of 2019.
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