Kitov Pharmaceuticals Holdings Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application (NDA 210045) filing fee for KIT-302. KIT-302 is Kitov's patented combination of Amlodipine Besylate-Celecoxib tablets, intended to treat osteoarthritis pain and hypertension simultaneously.
J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer, commented, "We are pleased to receive this NDA fee waiver for KIT-302 and look forward to continuing to work with the FDA through the NDA submission and review process. We are focused on finalizing our NDA submission to the FDA, which we expect will occur during the current calendar quarter."
The fee waiver, which Kitov requested in accordance with sections 736(d)(1)(D) of the Federal Food, Drug and Cosmetic Act, is granted to a small business for its first human drug application submitted to the FDA for review. The Company will not be required to remit the NDA filing fee, provided that the marketing application for KIT-302 is filed prior to March 27, 2018.