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 : EC700
Submitter : Mrs. Claudia Kasprzak Date & Time: 10/12/2005 06:10:59
Organization : Mrs. Claudia Kasprzak
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
This drug has not played out well and it appears to be a reckless abuse of a woman's body. Those who would tend to use it would be looking only for an out and not examining the potential danger.