Pharma major Lupin Limited (Lupin) announced the launch of Ethacrynic Acid Tablets USP, 25 mg, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. 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.

• 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.
• Short-term management of hospitalized pediatric patients, other than infants, with congenital heart
disease or the nephrotic syndrome.
• 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 (RLD: Edecrin®) had an annual sales of approximately USD 20 million in the U.S.
(IQVIA MAT December 2019).