Aurobindo Pharma Limited announced that its wholly-owned subsidiary, Eugia Pharma Specialities Limited, has secured final approval from the US Food and Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg. The approved product is bioequivalent and therapeutically equivalent to Votrient Tablets, 200 mg, of Novartis Pharmaceuticals Corporation.
The drug, indicated for adults with Advanced Renal Cell Carcinoma (RCC) and Advanced Soft Tissue Sarcoma (STS) who have undergone prior chemotherapy, is expected to launch in Q4FY25. According to IQVIA, the approved product has an estimated market size of USD 106 million for the 12 months ending October 2024.
This approval represents the 179th ANDA (Abbreviated New Drug Application) approval, including 8 tentative approvals, from Eugia Pharma Specialities Group facilities, which specialize in oncology oral and sterile specialty products.
About Aurobindo Pharma Limited
Aurobindo Pharma Limited, headquartered in Hyderabad, India, is an integrated global pharmaceutical company known for developing, manufacturing, and commercializing a wide range of generic pharmaceuticals and active pharmaceutical ingredients across more than 150 countries. With 29 manufacturing and packaging facilities approved by leading regulatory agencies worldwide, the company’s portfolio spans CNS, anti-retroviral, CVS, antibiotics, gastroenterological, anti-diabetic, and anti-allergic therapeutic areas. Aurobindo is supported by a robust R&D setup to drive innovation.
