Posted by Michael Wonder on 13 Jul 2019
Eton Pharmaceuticals provides update on EM-100 program
12 July 2019 - Eton Pharmaceuticals today announced that the U.S FDA provided Eton’s partner with a complete response letter relating to the application for EM-100.
No concerns were raised about the clinical data in the application, so it is not anticipated that any additional clinical work will be required.
A response to this letter is expected shortly, and the Company remains confident in the approvability of the product.
