Posted by Michael Wonder on 11 Apr 2022
Eton Pharmaceuticals announces FDA approval of cysteine hydrochloride injection
11 April 2022 - Eton Pharmaceuticals today announced that it has received final approval from the U.S. FDA for its cysteine hydrochloride abbreviated new drug application, a bioequivalent generic of Exela Pharma Sciences’ Elcys.
Eton was granted 180 days of generic exclusivity as a result of being the first abbreviated new drug application submitted against the reference product. The 180 day exclusivity period will begin upon Eton’s commercialisation of the product.
