June 20, 2020 / 1:03 AM / 24 days ago

BRIEF-Nabriva Therapeutics Receives Complete Response Letter From FDA On NDA For Contepo For Injection

June 19 (Reuters) - Nabriva Therapeutics PLC:

* NABRIVA THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM FDA ON NDA FOR CONTEPO™ (FOSFOMYCIN) FOR INJECTION

* FDA DID NOT REQUEST ANY NEW CLINICAL DATA & DID NOT RAISE ANY OTHER CONCERNS WITH REGARD TO SAFETY OR EFFICACY OF CONTEPO IN CRL

* CRL CITES OBSERVATIONS AT MANUFACTURING PARTNERS THAT COULDN’T BE RESOLVED DUE TO FDA’S INABILITY TO CONDUCT ONSITE INSPECTIONS

* CONTEPO BEEN GRANTED QUALIFIED INFECTIOUS DISEASE PRODUCT & FAST TRACK DESIGNATIONS BY FDA FOR TREATMENT OF SERIOUS INFECTIONS

* PLANS TO REQUEST TYPE A MEETING WITH FDA TO DISCUSS APPROPRIATE NEXT STEPS, FDA’S PLANS TO COMPLETE FOREIGN FACILITY INSPECTIONS Source text for Eikon: Further company coverage:

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