Lupin gets FDA green light for generic Edecrin

Lupin has received the Food and Drug Administration's approval for ethacrynic acid tablets in a dosage strength of 25 mg.

Lupin’s product is the generic of Bausch Health's Edecrin tablets, 25 mg.

It is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required; 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.

The product had a market value of approximately $24 million, according to IQVIA June 2019 data.