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 : EC1949
Submitter : Ms. T G Date & Time: 10/31/2005 04:10:01
Organization : DAC
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?
yes
GENERAL
GENERAL
I think this drug should be available OTC and by prescription. The community at large has been and will continue to be greatly helped by the availability of this EC drug.