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 : EC969
Submitter : Ms. Erika Jackson Date & Time: 10/27/2005 09:10:26
Organization : Ms. Erika Jackson
Category : Individual Consumer
Issue Areas/Comments
This question should have been settled years ago, when the agency's own advisory panel voted to approve EC over-the-counter. EC meets all of the criteria for OTC status: it's safe, it's effective and can be taken without supervision. I urge you to approve making EC available over the counter for all women.