Posted by Michael Wonder on 17 Sep 2020
Eton Pharmaceuticals provides update on the FDA review of EM-100
16 September 2020 - Eton Pharmaceuticals reported that its partner has not yet received a communication from the U.S. FDA regarding its decision on the review of EM-100.
EM-100’s Generic Drug User Fee Act target action date was 15 September.
The company is not aware of any information requests outstanding and expects the FDA to communicate a decision shortly.
