Teva Pharmaceutical has received the FDA approval for its New Drug Application (NDA) of Plan B One-Step emergency contraception (levonorgestrel tablet, 1.5mg).
With new Plan B One-Step, women can help prevent an unintended pregnancy after unprotected sex or contraceptive failure with just one pill in one dose, said the company.
FDA to expand OTC access to Plan B One-Step for consumers aged 17 or older.
Amy Niemann, General Manager and Senior Vice President of Teva Women’s Health, said: “We’re proud to offer women this new, innovative emergency contraceptive option that builds upon the trust that women have come to know with Plan B. Emergency contraception is more effective the sooner it’s taken, and with Plan B One-Step women can now act quickly and take it right away when the unexpected happens.
Plan B One-Step is manufactured in partnership with Teva Pharmaceutical Industries, by Gedeon Richter of Budapest, Hungary.