Aurobindo Pharma Limited on Thursday announced that its wholly owned subsidiary company, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg.
According to the company’s statement, it is the bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Votrient Tablets, 200 mg, of Novartis Pharmaceuticals Corporation.
“The product is expected to be launched in Q4FY25. The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA,” the company said in a statement.
This is the 179th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.
Pazopanib Tablets, 200 mg is indicated for the treatment of adults with Advanced Renal Cell Carcinoma (RCC), and Advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy, it added.
