FDA approves Eton Pharmaceuticals’ cysteine hydrochloride injection

Eton Pharmaceuticals announced Monday that the FDA has approved an abbreviated new drug application for its cysteine hydrochloride injection.

Cysteine is indicated for use as an additive to amino acid solutions to meet the nutritional requirements of newborn infants, the company explained. Before 2019, it was sold in the United States as a “grandfathered” or “unapproved” product.

Eton’s drug is a bioequivalent generic of Exela Pharma Sciences’ Elcys, which the FDA approved in 2019. The FDA granted Eton 180 days of generic exclusivity, which will begin once the product is commercialized, the company said.

Eton said it is currently engaged in litigation with Exela regarding its patents for Elcys, which Eton says is the “same formulation” as the grandfathered versions.

“We are pleased to see another one of our products receive FDA approval,” Eton CEO Sean Brynjelsen, MS, MBA, said in a statement.