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# FDA Grants Taiho Oncology Lonsurf Petition
- URL: https://www.fdaweb.com/fda-grants-taiho-oncology-lonsurf-petition/
- Published: 2022-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:53:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152369

FDA has granted a Taiho Oncology 2/10 petition asking that the agency not permit ANDA applicants citing Lonsurf (trifluridine and tipiracil) as the reference-listed drug to omit certain labeling information describing pharmacokinetics in and dosage reduction instructions for patients with severe renal impairment and other information from Taiho’s dedicated renal impairment study. The petition also asked FDA to require those ANDA applicants to submit a patent certification to one of the Lonsurf patents.

The FDA [response](https://downloads.regulations.gov/FDA-2022-P-0155-0006/attachment%5F1.pdf?ref=fdaweb.com) says several drug companies submitted comments on the petition asserting that omitting the Lonsurf labeling “would not render a proposed generic drug referencing Lonsurf ‘less safe and effective than Lonsurf for the remaining conditions of use.’”

However, FDA says its review of the petition, the comments, and the administrative record indicates that omitting patent-protected information concerning patients with severe renal impairment from labeling would render generic trifluridine/tipiracil tablets less safe than Lonsurf for all remaining, nonprotected conditions of use. “FDA agrees with Taiho that labeling of generic trifluridine/tipiracil tablets must retain the patent-protected dose reduction and related PK information for patients with severe renal impairment,” the letter says. FDA says it also agrees that a section viii statement is not permissible and a patent certification is required.