Par Pharmaceutical starts shipment of generic version of Sodium Edecrin

Par Pharmaceutical today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for ethacrynate sodium for injection USP, equivalent to ethacrynic acid 50 mg. Ethacrynate sodium is the generic version of Aton Pharma's Sodium Edecrin^® and is used in the treatment of edema. Par's ethacrynate sodium for injection USP, 50 mg is the first and only generic available.

Par has begun shipping ethacrynate sodium for injection USP, which is packaged in cartons of one 50 mg single-dose vial. According to IMS Health data, annual U.S. sales of Sodium Edecrin^® are approximately $40 million.