Natco Pharma gets final nod for Tipiracil Hydrochloride and Tifluridine Tablets

16 Jun 2023 Evaluate

Natco Pharma has received 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. Lonsurf is indicated primarily for the treatment of colorectal cancer. As per IQVIA data, Lonsurf had generated annual sales of $211 million in USA during the twelve months ending December 2022. 

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.

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850.95 -32.55 (-3.68%)
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