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 : EC776
Submitter : Ms. Corene Kendrick Date & Time: 10/13/2005 08:10:26
Organization : Ms. Corene Kendrick
Category : Individual Consumer
Issue Areas/Comments
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
Please approve Plan B ("Morning After Pill") as soon as possible as it will prevent unwanted pregnancies when contraception fails and will reduce the number of abortions in this country.