Lupin gets tentative USFDA approval for Obeticholic Acid tablet

Lupin has disclosed that it has obtained tentative approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Obeticholic Acid Tablets in 5 mg and 10 mg dosages, which is a generic version of Intercept Pharmaceuticals’ Ocaliva Tablets.

As per IQVIA MAT December 2022, in the United States, Obeticholic Acid Tablets (RLD Ocaliva) had an estimated annual sales of USD 255 million.

Obeticholic Acid Tablets are used to treat a certain type of liver disease known as primary biliary cholangitis (PBC) in combination with other medications, or when other treatments have failed.

It works by increasing the flow of bile in the liver, which helps to reduce the number of harmful substances in the liver.

At around AM, Lupin was trading at Rs650.70, 0.33% higher against the previous close of Rs648.55 on NSE. The counter opened at Rs651 and touched intraday high of Rs653.50.

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