Agenda April 22, 2002

Nonprescription Drugs Advisory Committee with consultants from
Pulmonary - Allergy and Dermatologic Drugs Advisory Committees
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, Bethesda

Claritin for OTC use (NDA 19-658, NDA 20-704 and NDA 20-641, loratadine, Schering - Plough)

8:00     Call to Order, Introductions
Louis Cantilena, M.D., Ph.D., NDAC Chair

             Conflict of Interest Statement
             Sandra Titus, Ph.D., Executive Secretary, NDAC

 8:15     Welcome and Introduction to Today’s Issues
             Charles Ganley, M.D., Director, Over-the -Counter Drugs

8 :30    Schering Plough Presentations:

            John Clayton, Ph.D, Senior VP Scientific and Regulatory Affairs

            Clinical Overview of Urticaria
            Eugene W. Monroe, M.D., Department of Dermatology, Medical College of Wisconsin

            Schering Studies on CIU
            Stephen Neuman, Senior Director, Marketing Support Services

            Risk-Benefit Analysis on CIU
            John Clayton, Ph.D.

9:30     Questions from the Committee to Schering Plough

10:00   Break

10:30   FDA Presentations:

 Urticaria An Overview  and OTC Considerations
            Jonathan Wilkin, M.D., Director, Dermatologic Drugs

Clinical Study Design Issues for the Approved H1 Antihistamines with CIU Indication
            Badrul  Chowdhury, M.D., Ph.D., Team Leader, Pulmonary and Allergy Drugs

             OTC Issues: US Regulatory History, Foreign Marketing and Label
             Comprehension Study
Matthew Holman, Ph.D., Interdisciplinary Scientist, Over-the-Counter Drugs

            Summary of Issues on Urticaria as an OTC indication
            Charles Ganley, M.D.

11:30   Questions from the Committee to the FDA

 12:00   Lunch Break

 1:00     Open Public Hearing

 2:00     Committee Discussion

 5:00     Adjourn