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 : EC2136
Submitter : Ms. Nicola Monat-Jacobs Date & Time: 10/31/2005 06:10:43
Organization : Ms. Nicola Monat-Jacobs
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Please approve Emergency Contraception (EC) for OTC status. It has been recommended for that status and these unprecendented delays are just ludicrous.