Posted by Michael Wonder on 15 Jan 2019
Nabriva Therapeutics provides update on PDUFA date for intravenous Contepo
14 January 2019 - PDUFA action date now set for 30 April 2019.
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 (NDA) from 30 June 2019 to 30 April 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.
