Iterum Therapeutics Provides Regulatory Update : comparemela

Iterum Therapeutics Provides Regulatory Update


Nachrichtenquelle: globenewswire
 |  02.07.2021, 00:30  | 
104 
 | 

DUBLIN, Ireland and CHICAGO, July 01, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation
oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company received a letter from the U.S. Food
and Drug Administration (“FDA”) stating that, as part of their ongoing review of the Company’s New Drug Application (“NDA”) for sulopenem etzadroxil/probenecid, the agency has identified
deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time. No details with respect to deficiencies were disclosed by the FDA

Related Keywords

Corey Fishman , , Executive Officer , கோரி மீன் , நிர்வாகி அதிகாரி ,

© 2025 Vimarsana