Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle
By
Dan Schiff / Email the Author / “The Tan Sheet” Dec. 12, 2011, Vol. 19, No. 50
Rx-to-OTC Switch / Word Count: 1144 / Article # 05111212013
Executive Summary
HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.
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