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FDA approves Plan B One-Step OTC switch

Agency complies with federal court order to remove age, point-of-sale restrictions on contraceptive pill

SILVER SPRING, Md. — The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

The FDA said the new approval of Teva Women's Health's Plan B One-Step (levonorgestrel) was to comply with an April 5 federal court order to make emergency contraceptives containing levonorgestrel available over the counter without age or point-of-sale restrictions.

The pill is designed to reduce the odds of pregnancy after unprotected sex or failure of other contraceptives, such as condoms. The agency notified a U.S. District Court in New York of its intention to follow the court's order to make such drugs available over the counter, and Teva was required to submit a regulatory application seeking approval of the pill as an OTC product. The drug was originally approved in 2009 without a prescription for girls and women aged 17 and older. In April of this year, that age threshold was lowered to 15, and the latest decision removes age requirements altogether.


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