Nabriva Therapeutics Announces Acceptance of New Drug Applications by the FDA for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults
DUBLIN, Ireland, Feb. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for both the intravenous (IV) and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia (CABP). The acceptance of lefamulin’s two NDAs indicates that the FDA has deemed both applications sufficiently complete to allow a substantive review. Both applications have been granted priority review and the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review is August 19, 2019. In addition to priority review, lefamulin has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA.
Article: NabrivaHealthy Patients Smart Innovations