FDA's Arthritis Advisory Committee

Executive Summary

On Jan. 28, the committee will address its "role...in the review" of Rx-to-OTC switches as well as "NDA Day" procedures and objectives. In June, the arthritis committee participated in a review of Syntex/P&G's Rx-to-OTC switch application for naproxen sodium with FDA's Nonprescription Drugs Advisory Committee. The first day of the meeting on Jan. 27 will be devoted to a review of Greenwich Pharmaceutical's NDA for Therafectin, a prescription drug. The meeting is scheduled to begin at 8:30 a.m. each day in conference rooms D & E of FDA's Parklawn Building in Rockville, Md