Natco Pharma’s abbreviated new drug software (ANDA) for Tipiracil Hydrochloride and Trifluridine Tablets has acquired the ultimate approval of U.S. Food and Drug Administration (U.S. FDA).
The product is a generic for Lonsurf, which is indicated primarily for remedy of colorectal cancer. Lonsurf is bought within the U.S. by Taiho Oncology Inc.
Natco believes it’s one of the first-to-file for the product and could also be eligible for a 180-day exclusivity on the time of the launch. Lonsurf had generated an annual gross sales of $211 million within the U.S. through the 12 months ended December 2022, the Hyderabad-based drugmaker on Friday stated, citing IQVIA information. Natco shares closed 1.57% decrease at ₹629.55 on the BSE.
