Planning Agenda

Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee.

Purpose of meeting:

The committees will consider Citizen Petition 98P-0610/CP1, submitted by Blue Cross of California, that requested the agency to convert fexofenadine hydrochloride, loratadine and cetrizine hydrocholoride to over-the-counter status. Background material, including the petition to switch the antihistamines to OTC status will be available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm.  Click on the year 2001 and go to the May 11th Nonprescription Drugs Advisory Committee file.

Where and When: .

The meeting will be held on May 11, 2001, 8 a.m. to 5 p.m. at the Holiday Inn, Two Montgomery Village Avenue, Gaithersburg, MD. The hotel phone number is 301-948-8900. The entire meeting is open and the public is invited to attend. You do not need to register to attend.

Public Participation at the Meeting:

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by May 2, 2001. (Contact Person: Sandra Titus or Kimberly Topper, at 301-827-7001, or e-mail: Tituss@cder.fda.gov. )

Planning Agenda (This may change.)

Overview on Purpose of the Meeting and what we hope to Accomplish

Presentation by the Petitioner: Why the drugs should go OTC

Open Public Hearing (1/2 hour)

Presentations by the three sponsors: Response to the Petition

FDA perspective on the Issues

Open Public Hearing (1/2 hour)

Discussion by the Committee