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 : EC1642
Submitter : Ms. Jane Shelly Date & Time: 10/31/2005 02:10:59
Organization : Ms. Jane Shelly
Category : Individual Consumer
Issue Areas/Comments
1
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
PLease approve without delay the over the counter "Plan B" drug!
GENERAL
GENERAL
Please approve without further delay the over the counter "Plan B"