Food and Drug Administration

Nonprescription Drugs Advisory Committee with consultants from
Pulmonary - Allergy and Dermatologic Drugs Advisory Committees

April 22, 2002

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



The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.

Claritin (10 mg loratiadine), OTC Indication for Chronic Idiopathic Urticaria, Schering Corporation   ppt   htm

FDA Opening   ppt   htm

Urticaria: Overview and OTC Considerations, Jonathan Wilkin, MD, FDA   ppt   htm

Clinical Development Programs for Chronic Idiopathic Urticaria Indication for H1-antihistamines, Badrul A Chowdhury, MD, PhD, FDA   ppt  htm

OTC Issues: U.S. Regulations, Foreign Marketing, and Label Comprehension Study Results, Matthew R Homan, PhD, FDA   ppt   htm

Summary of Issues on Urticaria as an OTC Indication, Charles Ganley, MD, FDA   ppt   htm

FDA Closing   ppt   htm