Dual Status Rx/OTC Plan B In The Works? Barr Weighs Its Options
This article was originally published in The Pink Sheet Daily
Executive Summary
Barr appears to be leaning toward a dual label Rx/OTC approach in seeking FDA approval to switch the emergency contraceptive Plan B (levonorgestrel)
You may also be interested in...
Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock
Response to "not approvable" letter for OTC availability of the emergency contraceptive includes information supporting Rx-only status for women 15 years of age and under and OTC status for women 16 and older.
Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock
Response to "not approvable" letter for OTC availability of the emergency contraceptive includes information supporting Rx-only status for women 15 years of age and under and OTC status for women 16 and older.
Plan B OTC Submission Deemed "Not Approvable"
Barr will have to detail a mechanism for drugstores to screen women less than 16 years of age for nonprescription use of the emergency contraceptive. FDA's decision goes against the recommendation of its advisory panels.