Food and Drug Administration

Food and Drug Administration

Joint Meeting of the

Psychopharmacologic Drugs Advisory Committee and

the Pediatric Advisory Committee

September 13-14, 2004

Addendum (dated 8/20/04) to

FDA Briefing Information

Tab 1: Product Labeling for Prozac® (fluoxetine hydrochloride) (June 11, 2004)

Tab 2: Product Labeling for Zoloft® (sertraline hydrochloride) Tablets and Oral

Concentrate (July 2004)

Tab 3: FDA Talk Paper (dated August 20, 2004): "FDA Updates Its Review of

Antidepressant Drugs in Children"

Tab 4: Draft Agenda for the September 13 and 14, 2004, Advisory Committee Meeting