2000 NDA approvals
This article was originally published in The Tan Sheet
Executive Summary
FDA approved 160 new drugs and devices in 2000, a Jan. 18 "Talk Paper" states. Agency specifically notes McNeil's Motrin, Whitehall-Robins' Advil, Pfizer/Warner-Lambert's Zantac 75 and Pharmacia's Nasalcrom added pediatric information to their labeling during the year. CDER approved 98 NDAs last year with an average approval time of 15 months. The center's 15-year high for NDA approvals was 1996, when it approved 131; its fastest average NDA approval times were seen in 1998 (12.8 months)