Brief: Nabriva Therapeutics Receives Complete Response Letter From FDA On NDA For Contepo For Injection
20/06/2020 02:00
June 19 (Reuters) - Nabriva Therapeutics PLC NBRV.O :
* 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: ID:nGNX8w2SdV
Further company coverage: NBRV.O
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