Posted by Michael Wonder on 14 Feb 2019
Motif Bio receives complete response letter from the FDA
14 February 2019 - Motif Bio announced today that the Company has received a complete response letter from the U.S. FDA regarding the new drug application for iclaprim for the treatment of acute bacterial skin and skin structure infections.
The letter states that the FDA cannot approve the application in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the application may be approved.
Motif Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.
