Posted by Michael Wonder on 03 Jul 2021
Iterum Therapeutics provides regulatory update
1 July 2021 - Iterum Therapeutics today announced that the Company received a letter from the U.S.FDA stating that, as part of their on-going review of the Company’s new drug application for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that preclude the continuation of the discussion of labelling and post marketing requirements/commitments at this time.
No details with respect to deficiencies were disclosed by the FDA in this notification and the letter further states that the notification does not reflect a final decision on the information under review.
In a letter to the Company dated 21 January 2021, the FDA had assigned a Prescription Drug User Fee Act goal date of 25 July 2021 for completion of its review of the new drug application.
