CHESTNUT RIDGE, N.Y., Aug. 4, 2015 /PRNewswire/ -- 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.
Aton Pharma is a division of Valeant Pharmaceuticals North America LLC.
Important Information About Ethacrynate Sodium for Injection
All diuretics, including ethacrynic acid, are contraindicated in anuria. If increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, or severe watery diarrhea, the diuretic should be discontinued. Parenteral ethacrynate sodium is contraindicated in infants and in any patient hypersensitive to any component of this product. Refer to full prescribing information for Warnings and Precautions at www.parpharm.com.
About Par Pharmaceutical
Par is a specialty pharmaceutical company that develops, manufactures and markets safe, innovative and cost-effective pharmaceuticals that help improve patient quality of life. Par Pharmaceutical offers a line of high-barrier-to-entry generic drugs, while Par Specialty Pharmaceuticals provides niche, innovative brands. Par Sterile Products develops, manufactures and markets both branded and generic aseptic injectable pharmaceuticals. For press release and other company information, visit www.parpharm.com.
SOURCE Par Pharmaceutical