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 : EC2090
Submitter : Mrs. Jackie Bodden Date & Time: 10/31/2005 06:10:26
Organization : Mrs. Jackie Bodden
Category : Health Professional
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?
Wouldn't this already be a statement in the OTC medications such as Zantac that has an OTC strength and a precription strength but both contain the same active ingredient.
3
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Just change the color of the packaging.
GENERAL
GENERAL
To not approve Plan B for OTC status for all women is a great disservice to women. Quit hiding behind all the politics and get it out there for consumers. You should be more conderned about other medications with many more side effects such as dextramethorphan or Nyquil that are readily OTC and more likely to be abused by teens.