Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle
This article was originally published in The Tan Sheet
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.
You may also be interested in...
Nearly 120 researchers, clinicians and advocacy groups have signed a letter to be sent in late August urging FDA to prioritize completion of a review process to make oral contraceptives available OTC.
Following accelerated approval of Biogen’s Alzheimer’s drug aducanumab in the US, we look back at 10 of the FDA’s most controversial drug approval decisions, from Addyi to Zohydro.
With action imminent on Biogen’s Alzheimer’s drug aducanumab, the Pink Sheet looks back at 10 of FDA’s most controversial drug approval decisions, from Addyi to Zohydro.