Pharma major Lupin Limited has launched United States Food and Drug Administration (FDA) approved ethacrynic acid tablets USP, 25 mg. The product would be manufactured at Lupin’s Nagpur OSD facility, India.
Ethacrynic acid tablets USP, 25 mg, is the generic equivalent of Edecrin tablets, 25 mg, of Bausch Health Americas, Inc. and are indicated for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required.
It is indicated for the treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.
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Intravenous ethacrynic acid sodium is indicated when a rapid onset of diuresis is desired, e.g, in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
Ethacrynic acid tablets USP had an annual sales of approximately US$ 20 million in the US (IQVIA MAT December 2019).