Natco Pharma gets USFDA approval for Tipiracil Hydrochloride and Trifluridine Tablets

Natco Pharma Ltd on Friday said it has received final approval from the US health regulator for its generic Tipiracil Hydrochloride and Trifluridine tablets indicated primarily for the treatment of colorectal cancer.

The US Food and Drug Administration (USFDA) granted final approval to the abbreviated new drug application (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets, the generic version of Lonsurf sold in the US by Taiho Oncology Inc, Natco said in a regulatory filing.

"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," it added.
Lonsurf had generated annual sales of $211 million in the US during the 12-month period ended December 2022, the company said citing IQVIA data.