Mumbai, Baltimore: 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).

About Lupin Limited

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions and in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin has 15 manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.

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*Safe Harbor Statement

Edecrin® is the registered trademark of Bausch Health Ireland Limited