Lupin bags tentative approval for Ocaliva Tablets generic in US

Lupin said that it has been issued tentative approval for Obeticholic Acid Tablets, 5 mg and 10 mg from the US Food and Drug Administration (FDA).

The Indian pharma company approval is for the abbreviated new drug application (ANDA) for marketing a generic version of Intercept Pharmaceuticals’ Ocaliva Tablets, 5 mg and 10 mg.

As per the FDA, OCALIVA is a farnesoid X receptor (FXR) agonist, approved for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adult patients with insufficient response to UDCA, or as monotherapy in adults who cannot tolerate UDCA.

According to IQVIA MAT December 2022, the estimated annual sales of Obeticholic Acid Tablets in the US is $255 million.