Ketoprofen Phase IV trials for headache claim, dysmenorrhea dosing suggested by cmte.
This article was originally published in The Tan Sheet
Executive Summary
KETOPROFEN PHASE IV TRIALS FOR HEADACHE, DYSMENORRHEA SUGGESTED by FDA's Arthritis and Nonprescription Drugs Advisory Committees at a July 14 joint meeting in Rockville, Md. Summarizing the committee's discussion of the headache indication, NDAC Chair Randy Juhl, PhD, University of Pittsburgh, stated that "the data isn't as clear as we would like it to be."