United States — Food and Drug Administration & Astellas Pharma

United States — Food and Drug Administration: The United States — Food and Drug Administration granted tentative approval for Lupin (company)'s Enzalutamide Tablets, acting as the regulatory body overseeing drug approvals in the U.S.

Astellas Pharma: Astellas Pharma is the manufacturer of the reference listed drug Xtandi Tablets, to which Lupin (company)'s Enzalutamide Tablets were found bioequivalent. This approval could introduce competition for Astellas Pharma's product.