Nabriva Therapeutics receives complete response letter from FDA on NDA for Contepo (fosfomycin) for injection

Nabriva Therapeutics

19 June 2020 - Agency cited travel restrictions and inability to conduct onsite inspections to resolve observations at manufacturing partner facilities.

Nabriva Therapeutics announced today that it received a complete response letter from the U.S. FDA for the new drug application  resubmission seeking marketing approval of Contepo (fosfomycin) for injection for the treatment of complicated urinary tract infections, including acute pyelonephritis.

Read Nabriva Therapeutics press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US