Paratek Announces Acceptance of European Marketing Authorization Application for Oral and Intravenous Omadacycline
Paratek Pharmaceuticals, Inc. (PRTK)
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Source: GlobeNewswire
-- MAA submission for both community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) -- -- EMA decision expected second half of 2019 -- BOSTON, Oct. 04, 2018 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced the acceptance of the submission to the European Medicines Agency (EMA) of the Marketing Authorization Application (MAA) for omadacycline. Paratek is seeking approval of omadacycline, a modernized tetracycline, for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Omadacycline is a once-daily oral and intravenous (IV) broad spectrum antibiotic approved under the tradename NUZYRA™ in the United States. The MAA is supported by the company’s Phase 3 program for omadacycline, which included three pivotal registration studies: two studies in ABSSSI and one study in CABP. Omadacycline met all required EMA primary endpoi
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