August 22, 2006
Barr resubmits Plan B application
Barr Pharmaceuticals Friday resubmitted an application seeking FDA approval to sell its emergency contraceptive Plan B without a prescription.
The contents of the resubmitted application were not disclosed.
“Currently we remain committed to an expeditious review,” FDA spokeswoman Susan Bro told The Wall Street Journal. Bro did not say when the FDA would decide on the application.
Last month, the FDA announced a framework to resolve policy issues associated with Plan B as an over-the-counter option, just prior to acting agency commissioner Andrew von Eschenbach’s scheduled testimony at a Senate hearing on his nomination to become permanent agency chief.
The Senate confirmation committee did not vote on von Eschenbach’s nomination.
Sens. Hillary Clinton, D-NY and Patty Murray, D-Wash., have placed a hold on the nomination until the FDA makes a final Plan B decision.