Final Questions - May 11, 2001

Joint Meeting - Nonprescription Drugs Advisory Committee &

Pulmonary - Allergy Drugs Advisory Committee

 

 

  1. Does loratadine have a safety profile acceptable for OTC marketing , i.e., can it be used safely without a learned intermediary?
    1. If no, what safety or other clinical issues should be addressed prior to OTC marketing?

b. If yes, what statements, related to sedation or any other safety issues should be included in OTC labeling?

 
  1. Does fexofenadine have a safety profile acceptable for OTC marketing , i.e., can it be used safely without a learned intermediary?
    2.

    a. If no, what safety or other clinical issues should be addressed prior to OTC marketing?

    b. If yes, what statements, related to sedation or any other safety issues should be included in OTC labeling?

     

  2. Does cetirizine have a safety profile acceptable for OTC marketing , i.e., can it be used safely without a learned intermediary?

a. If no, what safety or other clinical issues should be addressed prior to OTC marketing?

b. If yes, what statements, related to sedation or any other safety issues should be included in OTC labeling?