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# Kitov Pharma Planning NDA for Combo of 2 Pfizer Drugs
- URL: https://www.fdaweb.com/kitov-pharma-planning-nda-for-combo-of-2-pfizer-drugs/
- Published: 2016-12-07T12:00:00.000Z
- Updated: 2026-09-14T21:52:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137516

Kitov Pharmaceuticals Holdings says it has completed FDA-required stability testing on nine pivotal batches of KIT-302, three in each dosage form (celecoxib/amlodipine of 200 mg/10 mg, 200 mg/5 mg, and 200 mg/2.5 mg). The testing met the criteria demonstrating stability for six months, which will allow an NDA submission in the first quarter of 2017, the company says. Kitov expects to submit additional stability data to FDA at a later time in order to extend the labeled shelf life.

  
KIT-302 is a fixed dose combination consisting of 200 mg of celecoxib (Pfizer’s Celebrex), indicated for osteoarthritis pain, and 2.5, 5 or 10 mg of amlodipine (Pfizer’s Norvasc), indicated for high blood pressure. It is intended to treat pain caused by osteoarthritis, as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition.