Aurobindo Pharma's subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg, a generic equivalent to Novartis' Votrient. This approval allows Eugia Pharma to address the market for this cancer treatment medication in the United States, with the product expected to launch in Q4FY25.
Pazopanib is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS) in patients who have received prior chemotherapy. RCC is a type of kidney cancer that accounts for approximately 90% of kidney malignancies. STS are a diverse group of tumors that arise from mesenchymal tissues, with an annual incidence of approximately 5 per 100,000 people.
The approval of Eugia Pharma's Pazopanib tablets offers a cost-effective alternative to Votrient, potentially increasing access to this important medication for patients with advanced RCC and STS. According to IQVIA data, the market size for Pazopanib Tablets reached an estimated $106 million for the 12-month period ending October 2024.
This approval marks the 179th Abbreviated New Drug Application (ANDA) approval for Eugia Pharma Specialities Group (EPSG). Eugia Pharma Specialities Group specializes in manufacturing both oncology oral and sterile specialty products. Aurobindo Pharma has 29 manufacturing facilities approved by major international regulatory agencies. The company develops and commercializes generic pharmaceuticals across seven therapeutic areas in over 150 countries.
