Posted by Michael Wonder on 09 Oct 2020
Eton Pharmaceuticals announces acceptance for filing of new drug application for orphan drug dehydrated alcohol injection
8 October 2020 - Application assigned a PDUFA date of 27 May 2021.
Eton Pharmaceuticals today announced the U.S. FDA has accepted for filing the company’s new drug application for dehydrated alcohol injection.
Eton’s application previously received orphan drug designation for the treatment of methanol poisoning and is expected to receive seven years of market exclusivity upon its approval.
