FDA Grants Teva’s Plan B One-Step Three Years of Exclusivity

The FDA without fanfare last week quietly updated the Orange Book to show that Teva’s Plan B One-Step has been awarded three years of exclusivity, blocking generics through April 30, 2016. The decision resolves a lingering question left in the wake of the years-long battle over access to levonorgestrel-containing emergency contraceptives, which ended in June after the FDA, acting on an April 5 court order, approved Teva’s one-pill product for sale without a prescription for all women of child-bearing potential.
Washington Drug Letter