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
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
4/12/01 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