Barr Submits Plan B Response To FDA, Starts 180-Day Review Clock
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
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FDA’s Morning After The Inauguration: No Plan B Decision
The agency was unable to reach a decision on Barr’s application for an OTC switch of the emergency contraceptive by the Jan. 21 user fee date; Barr expects a decision from FDA “in the near future.”
FDA’s Morning After The Inauguration: No Plan B Decision
The agency was unable to reach a decision on Barr’s application for an OTC switch of the emergency contraceptive by the Jan. 21 user fee date; Barr expects a decision from FDA “in the near future.”
Barr's Plan B OTC Switch User Fee Date Arrives Jan. 21
The application's user fee goal date is actually Jan. 20, which is Inauguration Day and a federal holiday in the D.C. area, thereby pushing the deadline back a day. Barr seeks OTC status for women over age 16 and Rx status for younger women.