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
Original NDA Review pdf
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