USFDA gives tentative approval to Lupin’s prostate cancer tablets

Global pharma major Lupin Limited recently announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg.

Approval is granted to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Apalutamide Tablets, 60 mg, (RLD Erleada) had estimated annual sales of USD 1,185.5 million in the U.S., as per IQVIA MAT July 2023.