FDA approves Teva’s new formulation for emergency contraceptive

NORTH WALES, Pa. Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has approved Plan B One-Step as an over-the-counter emergency contraceptive for females ages 17 and older. The new Plan B One Step is the former two-pill regimen — used to help prevent an unintended pregnancy after unprotected sex or contraceptive failure — now as just one pill in one dose.

OTC availability for women ages 17 is new as well — a federal judge ordered FDA to lower the OTC age limit for Plan B from 18 to 17 in April, though the agency noted it would need a new drug application from Teva in order to accomplish that.

Plan B One Step will begin shipping by August, Teva reported.

“With Plan B One-Step, emergency contraception is now available in just one pill that can be taken right away when the unexpected happens,” stated Amy Niemann, general manager and SVP of Teva Women’s Health. “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.”

“I prefer one-pill dosing for my patients because it allows them to act more quickly, while providing a high level of safety and efficacy,” commented Ashlesha Patel, division director of Family Planning Services, John H. Stroger, Jr., Hospital. “Emergency contraception is more effective the sooner it’s taken, and Plan B One-Step provides a back-up plan that’s just one pill away.”

Awareness of Plan B has increased significantly since OTC approval in 2006, Teva reported. More than 88% of 18-to-30-year-olds categorize Plan B as emergency contraception, up from 64% in 2006. And 86% of individuals understand that the product prevents rather than terminates pregnancy, unlike the prescription “abortion pill” RU-486.

Additionally, U.S. retail pharmacists are overwhelmingly compliant with dispensing guidelines. Within one year post OTC approval, 99% of pharmacists who sold Plan B were aware of its dual-label status (it’s prescription-only for women younger than 17) and 95% were comfortable selling/dispensing Plan B.

Teva’s original Plan B formulation was opened to generic competition last month, as Watson Laboratories obtained approval for its Next Choice levonorgestrel brand, though only as a prescription for women younger than 17. Teva has patent protection on the OTC indication through Aug. 24.

For the 12-months ended March 2009, Plan B had total U.S. sales of approximately $123 million, of which approximately 10% are attributable to prescription sales, Watson reported, citing IMS sales data.