Aurobindo Pharma's Eugia Pharma Receives USFDA Approval for Generic Pazopanib Tablets
核心洞察
Eugia Pharma Specialities (搜索), a subsidiary of Aurobindo Pharma, has secured USFDA (搜索) approval to manufacture and market Pazopanib Tablets (200 mg) in the US.
The generic drug is therapeutically equivalent to Novartis' Votrient and is indicated for advanced Renal Cell Carcinoma (搜索) and Soft Tissue Sarcoma (搜索) after chemotherapy.
The product is slated for launch in Q4FY25, with an estimated market size of $106 million for the 12 months ending October 2024.
Aurobindo Pharma's subsidiary, Eugia Pharma Specialities (搜索) Limited, has received final approval from the US Food and Drug Administration (USFDA (搜索)) 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 (搜索) (RCC) and advanced soft tissue sarcoma (搜索) (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 (搜索) 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.