In a significant development for its oncology portfolio, Aurobindo Pharma announced that its wholly-owned subsidiary, Eugia Pharma Specialities, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Pazopanib Tablets (200 mg) in the US market.
The Hyderabad-based pharmaceutical giant disclosed this milestone in a regulatory filing, stating that its product is therapeutically equivalent to Novartis Pharmaceuticals Corporation&rsquo;s Votrient tablets, also in the 200 mg dosage form. Pazopanib Tablets are primarily used in the treatment of advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS) in adults who have undergone prior chemotherapy.
According to the company, the product is set to be launched in the fourth quarter of the financial year 2025 (Q4FY25). This marks a strategic addition to Aurobindo Pharma&rsquo;s oncology offerings, leveraging its extensive manufacturing and distribution capabilities in the competitive US market.
Market analysis from IQVIA estimates that the Pazopanib Tablets 200 mg market in the US is valued at approximately USD 106 million for the 12-month period ending October 2024. The approval and anticipated launch are expected to bolster Aurobindo&rsquo;s market presence in the high-value cancer treatment segment.
Despite this positive regulatory development, Aurobindo Pharma's shares on the Bombay Stock Exchange (BSE) closed 0.98% lower on Thursday at ₹1,245.70 per share. The company&rsquo;s stock movement reflects the broader trends in the pharmaceutical sector and investor sentiment.
This approval underscores Aurobindo Pharma&rsquo;s commitment to expanding its specialty pharmaceuticals and oncology portfolio globally while offering cost-effective therapeutic alternatives to patients battling advanced cancers. The company aims to maintain its position as a key player in the global pharmaceutical landscape through continued innovation and strategic market entries.
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<span style="font-size: 12.0pt; line-height: 107%; font-family: 'Verdana',sans-serif; mso-fareast-font-family: Calibri; mso-fareast-theme-font: minor-latin; mso-bidi-font-family: 'Times New Roman'; mso-bidi-theme-font: minor-bidi; mso-ansi-language: EN-IN; mso-fareast-language: EN-US; mso-bidi-language: AR-SA;">Source : The Economic Times

In a significant development for its oncology portfolio, Aurobindo Pharma announced that its wholly-owned subsidiary, Eugia Pharma Specialities, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Pazopanib Tablets (200 mg) in the US market.

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