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 : EC1929
Submitter : Dr. Patricia Lohr Date & Time: 10/31/2005 04:10:30
Organization : University of Pittsburgh, Magee-Womens Hospital
Category : Academia
Issue Areas/Comments
GENERAL
GENERAL
Plan B should be available over the counter and without age restriction as per the original recommendations of your advisory committee. This is an extremely safe medication that has the potential to decrease the number of unplanned pregnancies and the negative consequences of an unintended pregnancy.