georgian21 last edited by
Let’s say product A contains mg of sodium. We are finding that HCPs have little context to assess whether this amount is high or low. Would PAAB accept a sodium comparison based on the labels of the various products – these drugs being OTC and/or Rx – if they are from different categories and have different indications
Jennifer Carroll last edited by
Happy Friday @georgian21
PAAB Code section 5.1 states “The compared drugs/products have an authorized indication for use in common, and the comparison is related to that use; or, in addition to the common indication for use, a second authorized indication is claimed as an added benefit of the advertised drug”. As such, this type of comparison would not be acceptable.