Lupin gets tentative nod from US FDA for apalutamide tablets

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg, to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech.

This product will be manufactured at Lupin’s Pithampur facility in India.

Apalutamide Tablets, 60 mg, (RLD Erleada) had estimated annual sales of $1,185.5 million in the US (IQVIA MAT July 2023).