Taiho Pharmaceutical Co., Ltd. – FDA EIR, May 22, 2015

An FDA Pre-Approval inspection was conducted at Taiho Pharmaceutical Co., Ltd. from May 18 to May 22, 2015. The inspection's primary objective was to support New Drug Application (NDA) 207981/000 for Lonsurf (Trifluridine and Tipiracil HCl) immediate release film-coated tablets. The regulatory framework for this inspection included procedures outlined in CP 7346.832 for Pre-Approval Inspections and CP 7356.002 for Drug Manufacturing Inspections. The inspection comprehensively reviewed the company's Quality, Facilities and Equipment, Materials, Production, and Laboratory Control systems. Importantly, no formal inspectional observations (Form FDA 483) were issued to Taiho Pharmaceutical Co., Ltd. The only discussion with management during the inspection pertained to a change in the expiration date on a label for a finished bulk product. The inspection concluded with a "No Action Indicated" (NAI) classification, signifying no immediate regulatory actions were required. Subsequently, an approval recommendation for NDA 207981 was forwarded, and the firm will be re-inspected as part of the standard workplan.