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Zydus Cadila has received final approval from the US health regulator to market Ethacrynate sodium for injection, used to reduce swelling caused by various diseases.
The company has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 50 mg/vial, Zydus Cadila said in a BSE filing.
The company will produce the drug at its formulations manufacturing facility in Moraiya, Ahmedabad.
Ethacrynate sodium for injection is used to reduce swelling caused by various diseases including related to liver, kidney, congestive heart failure and cancer.
The company has more than 165 approvals and so far filed over 300 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.