Novugen Launches Pazopanib Tablets, 200mg, in the U.S. Following ANDA Approval by USFDA – PR.com

Princeton, NJ, May 07, 2024 –(PR.com)– Novugen is pleased to announce the launch of Pazopanib tablets, 200mg, in the U.S. This significant milestone follows the company’s recent Abbreviated New Drug Application (ANDA) approval by United States Food and Drug Administration (USFDA) on April 23, 2024. Pazopanib is the generic equivalent of Votrient and is manufactured by Novartis. According to IPD Analytics December 2023, Pazopanib had estimated annual sales of USD 188 million in the United States.

Pazopanib is an anticancer drug indicated for the treatment of advanced renal cell carcinoma (RCC) and advanced soft tissue sarcoma (STS). Despite its established efficacy, the drug’s difficult-to-develop formulation and complex manufacturing processes have limited market competition, making Novugen’s entry into the U.S. market a significant achievement.

“We are proud to bring Pazopanib tablets, 200mg, to the U.S., providing greater access to treatment for patients with advanced renal cell carcinoma and soft tissue sarcoma,” said Rahil Mahmood, CEO of Novugen. “This is a complex product that requires bioequivalence on cancer patients, which is a testament to Novugen’s strong research and development capabilities.”

Novugen’s commitment to improving patient access extends beyond the U.S. market. The company plans to expand distribution of Pazopanib to Malaysia and other Southeast Asian countries, where robust alternatives are often lacking. By introducing this crucial treatment option in regions with unmet medical needs, Novugen aims to enhance the quality of care for cancer patients worldwide.