Natco Pharma gets USFDA nod for Tipiracil Hydrochloride and Trifluridine Tablets
Lonsurf is indicated primarily for the treatment of colorectal cancer.
Hyderabad: Natco Pharma Limited has announced final approval for its Abbreviated New Drug Application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets (generic for Lonsurf) from the U.S. Food and Drug Administration (USFDA).
Lonsurf is sold in the US by Taiho Oncology Inc.
"Natco believes it is one of the First-to-File for the product and may be eligible for a 180-day exclusivity at the time of launch," the company stated.
Lonsurf is indicated primarily for the treatment of colorectal cancer.
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According to World Health Organisation (WHO), Colorectal cancer is the third most common cancer type worldwide; in 2020, almost 2 million cases were diagnosed. Colorectal cancer is the second most common cause of cancer death, leading to almost 1 million deaths per year.
As per IQVIA data, Lonsurf had generated annual sales of $211 million in USA during the twelve months ending December 2022.
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Natco Pharma Limited is a vertically integrated and R&D focused pharmaceutical company engaged in developing, manufacturing and marketing of finished dosage formulations (“FDF”) and active pharmaceutical ingredients (“APIs”). The company's focus is primarily on niche therapeutic areas and complex products. It markets and distributes products in over 40 countries. It sells FDF products in the United States, India, Europe and the rest of the world (“RoW”). Natco also operates in certain key geographies through its subsidiaries.
Natco Pharma is also engaged in contract manufacturing business, whereby it undertakes selected contracts with pharmaceutical companies to manufacture and supply pharmaceutical products.
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