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 : EC885
Submitter : Dr. Stephanie Van Zandt Date & Time: 10/17/2005 11:10:25
Organization : FACOG
Category : Health Professional
Issue Areas/Comments
Dear Acting Commissioner von Eschenbach and committee:
AS an OB/GYN, I am deeply disturbed by the FDA's repeated delays in approving OTC use of Plan B emergency contraception. Please approve Barr Labs application for OTC sales in order to provide our patients safe and effective contraception that would reduce unintended pregnancies and abortions. Thank you for your immediate action. Sincerely, Stephanie Van Zandt, MD FACOG