2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC487
Submitter : Dr. Thomas Purdon Date & Time: 09/27/2005 08:09:38
Organization : United Community Health Centers
Category : Health Professional
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Please proceed without further delaying tactics to approve Plan B for OTC use. The hormones are same, the women using the product will know exactly what they are using it for and it will help prevent unplanned and unwanted pregnancies, and therefore prevent the agony of having to conside abortion later on.
GENERAL
GENERAL
See above
Thomas F. Purdon, MD