|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|
| 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.