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news.The US Food and Drug Administration has granted final approval for Par Pharmaceutical's abbreviated new drug application (ANDA) for ethacrynate sodium for injection USP, equivalent to ethacrynic acid 50mg.
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Par’s ethacrynate sodium is the generic version of Valeant Pharmaceuticals North America division Aton Pharma’s Sodium Edecrin, which is indicated for the treatment of edema.
According to the company, its ethacrynate sodium for injection USP, 50mg is the first and only generic available.
The company has already started shipping ethacrynate sodium for injection USP, which is packaged in cartons of one 50mg single-dose vial.
Annual US sales of Sodium Edecrin are about $40m, according to IMS Health data.
The company noted that all diuretics, including ethacrynic acid are contraindicated in anuria and 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.
Par is focused on developing, manufacturing and marketing safe and cost-effective pharmaceuticals that help improve patient quality of life.