Food and Drug Administration

Nonprescription Drugs Advisory Committee
with consultants from the
Pulmonary and Dermatologic Advisory Committee

April 22, 2002

Claritin (loratadine, Schering Plough) for OTC use with indication for relief of symptoms associated with allergic rhinitis and chronic idiopathic urticaria (CIU), NDA 19-968, 20-704, 20-641

Briefing Information

Sponsor

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.

Schering Corporation, Background Information   pdf

Food and Drug Administration

Executive Summary   pdf   htm  doc

Pulmonary Summary   pdf   htm   doc

Original NDA Review   pdf

OTC Review   pdf   htm   doc

OTC Evaluation on Label and Self Recognition of CIU and Label Comprehension Study   pdf   htm   doc

OTC History with CIU   pdf

Physician Habits and Practices Study   pdf

Consumer Habits and Practices Study   pdf

Expert Panel Report on CIU    pdf

Label Comprehension Study   pdf

Draft Label Tested  pdf