Valeo Pharma Receives FDA Approval for Ethacrynate Sodium

Valeo Pharma has received approval for its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Ethacrynate Sodium 50 mg.

"We are pleased to have received the FDA's authorization to begin commercializing Ethacrynate Sodium in the U.S.. This is the first regulatory approval we have received from the FDA and we expect sales of Ethacrynate Sodium to start this summer," said Steve Saviuk, Valeo's President and CEO. "In addition to Ethacrynate Sodium and our recent approval of Yondelis by Health Canada, we expect several additional Canadian regulatory approvals over the coming months".

Valeo's Ethacrynate Sodium will be distributed in the U.S. through its commercial partner. Valeo has been commercializing Ethacrynate Sodium in Canada since the third quarter of 2018 and owns the world wide rights to the product (ex-Italy). Valeo intends to pursue Ethacrynate Sodium out-licensing opportunities in other territories.

Ethacrynate Sodium injection belongs to a group of medicines called loop diuretics. Ethacrynate Sodium is administered to treat fluid retention (edema) and swelling that is caused by congestive heart failure, acute pulmonary oedema, renal oedema, hepatic cirrhosis with ascites or other medical conditions.