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  1. Aurobindo Pharma’s arm gets USFDA’s approval for Pazopanib Tablets

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Aurobindo Pharma’s arm gets USFDA’s approval for Pazopanib Tablets

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1 min read | Updated on December 05, 2024, 16:59 IST

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SUMMARY

The approved product has an estimated market size of $106 million as of Oct 2024. This is the 179th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, which manufacture both oncology oral and sterile speciality products.

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Aurobindo Pharma’s arm gets USFDA’s approval for Pazopanib Tablets

Aurobindo Pharma’s wholly owned subsidiary -- Eugia Pharma Specialities, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pazopanib Tablets, 200 mg, which is 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, with an estimated market size of $106 million for the twelve months ending October 2024, according to IQVIA.

This is the 179th ANDA approval (including 8 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, which manufacture both oncology oral and sterile speciality products.

Pazopanib Tablets, 200 mg, are indicated for treating adults with Advanced Renal Cell Carcinoma (RCC) and Advanced Soft Tissue Sarcoma (STS) who have received prior chemotherapy.

Aurobindo Pharma manufactures pharmaceutical products. It offers active pharmaceutical ingredients, intermediates, and generic formulations like astemizole, domperidone, and omeprazole; anti-infective, oral, and sterile antibiotics; pain management; and osteoporosis segments.

Shares of Aurobindo Pharma closed 1.1% lower on the NSE at ₹1,245 apiece. On a YTD basis, the shares of the company delivered moderate returns of 15% and 20% on annual basis.

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