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 : EC545
Submitter : Dr. Susan Shultz Date & Time: 10/03/2005 03:10:43
Organization : Cascadia Health Care, P.C.
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I would like the FDA to approve the OTC sale of the emergency contraceptive pill Plan B. I have seen cases when this would have greatly helped the woman involved. It is a very stressful time for a woman. The OTC sale would eliminate some of this stress.