FDA Background*

Joint Meeting of the

Nonprescription Drugs Advisory Committee &

Pulmonary Allergy Drugs Advisory Committee

May 11, 20001

Issue: Petition 98P-0610/CP1 from Blue Cross of California Pharmacy requesting fexofenadine hydrochloride, loratadine and cetrizine hydrocholoride to OTC status

FDA Overview of the Issues   pdf   html

Executive Summary on Risk Issues   pdf   html

OTC Overview of Issues Memo   pdf   html

1976 - Panel Report on Issues of OTC Antihistamines (41FR38311 September 9, 1976)   pdf

1979 - Issue Relevant to Monograph (Warner-Lambert) (44FR51512 August 31, 1979)  pdf

1985 - Tentative Final Monograph (50FR2200 January 15, 1985)   pdf

1987 - Tentative Final Monograph (52FR31891 August 24, 1987)   pdf

1992 - Final Monograph   (57FR58355   December 9, 1992)   pdf

Labels for Allegra, Claritin and Zyrtec

Additional Submissions from the public to Docket 98P-0610/CP 1

4/11/01 Abstract from Blue Cross of California   pdf   html

4/12/01 Briefing Book from Schering-Plough   pdf   html

Submission on Behalf of Pfizer, Inc., Peter Hutt, et al. Covington & Burling (PDF)

Comment From Aventis Pharmaceuticals, Gillian Ivers-Read (PDF)

*Petition (98P-0610/CP1) submitted by Blue Cross of California Pharmacy requesting the Agency to switch Allegra (fexofenadine, Aventis), Claritin (loratadine, Schering-Plough) and Zyrtec (cetrizine, Pfizer) to over-the-counter status has been distributed to the committees and has been simultaneously available to the public at:

Petition: http://www.fda.gov/ohrms/dockets/dockets/98p0610/cp00001.pdf

Submissions to the Docket:  http://www.fda.gov/ohrms/dockets/dockets/98p0610/98p0610.htm