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 : EC890
Submitter : Dr. Louann Brizendine Date & Time: 10/17/2005 11:10:56
Organization : UCSF MEDICAL SCHOOL
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Plan B as both over the counter and RX should be approved. This will allow for conerns regarding age limits in teens to be addressed and allow this valuable active ingredient to become easily avaialable to adult women.
Louann Brizendine, M.D.
graduate 1981YALE MEDICAL SCHOOL