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FDA grants Kitov waiver for New Drug Application filing fee

Kitov Pharmaceuticals Holdings Ltd, a NASDAQ and TASE listed innovative biopharmaceutical company, said Monday that that the U.S. Food and Drug Administration (FDA) has granted Kitov a waiver related to the $2,038,100 New Drug Application filing fee for Kitov’s patented combination of Amlodipine Besylate-Celecoxib tablets, KIT-302.

The tablets are 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, said that the NDA fee waiver for KIT-302 should be finalized in this year.

The fee waiver, which Kitov requested in accordance with certain sections 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 said it 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.

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