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 : EC2023
Submitter : Ms. Lisa Chernin Date & Time: 10/31/2005 05:10:12
Organization : Ms. Lisa Chernin
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?
See general comment at the bottom
1.
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the act regarding when an active ingredient can be simultaneously market in both a prescription drug product and an OTC drug product?
See general comment at the bottom
GENERAL
GENERAL
My comment on this docket is that there is no medical evidence supporting the rulemaking process for this product. The medical evidence is clear, that the product is safe for general use. The rulemaking process is simply delaying the availability of a safe, useful, and important medication for women. Please make the product available immediately, for over-the-counter use.