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 : EC640
Submitter : Dr. Susan Hartley Date & Time: 10/12/2005 06:10:33
Organization : Dr. Susan Hartley
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Re. Plan B: Please consider refusing to make this product available over-the-counter. Side effects (such as retinal hemorrhages, etc.), especially with repeated use, warrant caution in prescribing this product for women of any age. There are good reasons why the milder products are available by prescription only, as should Plan B.
Thank you.