1. Pink Sheet

Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle

 
• By Dan Schiff

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.

Teva Pharmaceutical Industries Ltd. faces an unprecedented challenge in its pursuit of OTC access for emergency contraceptive Plan B One-Step after a surprising rejection by Department of Health and Human Services Secretary Kathleen Sebelius.

Despite FDA’s recommendation of approval, Sebelius said the label comprehension and actual use data Teva submitted in its February supplemental new drug application for Plan B One-Step (levonorgestrel 1

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from United States

More from North America