Nabriva Therapeutics announced that the U.S. FDA has updated the PDUFA goal date for the completion of the FDA’s review of the CONTEPO New Drug Application from June 30, 2019 to April 30, 2019. The two-month acceleration is due to a clarification of the classification and subsequent expedited review period for the CONTEPO NDA submitted in October 2018. In addition to priority review, CONTEPO has been granted Qualified Infectious Disease Product and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.
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