Teva’s One-Step Emergency Contraceptive gets FDA Approval

13 July 2009 (Last Updated July 13th, 2009 18:30)

Teva Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for its Plan B One-Step emergency contraceptive. The FDA gave approval following a successful New Drug Application for the tablet (levonorgestrel tablet, 1.5mg), which can be used after unprotected se

Teva Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for its Plan B One-Step emergency contraceptive.

The FDA gave approval following a successful New Drug Application for the tablet (levonorgestrel tablet, 1.5mg), which can be used after unprotected sex or contraceptive failure with just one pill in one dose.

The FDA is now deciding whether to expand over-the-counter access for the contraceptive to consumers aged 17 or older.

Teva Women's Health general manager and senior vice-president Amy Niemann said that the company was proud to offer women this new and innovative emergency contraceptive option that builds on the trust 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 act quickly and take it right away when the unexpected happens," Niemann said.