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)
Slides
Disclaimer
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
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