Lupin Gains Tentative FDA Approval For Apalutamide Tablets
Lupin on Friday received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Apalutamide Tablets, 60 mg, to market a generic equivalent of Erleada Tablets, 60 mg of Janssen Biotech, the company said in an exchange filing.
The Apalutamide Tablets, 60 mg will be manufactured at Lupin’s Pithampur facility in India, the company's statement informed.
Apalutamide Tablets, 60 mg, (RLD Erleada) ,a medicine used to treat prostate cancer in men ,had estimated annual sales of USD 1,185.5 million in the U.S. (IQVIA MAT 2023).
The company develops and commercialises a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets. Lupin currently has 15 manufacturing sites, and 7 research centres.
