FDA approves Plan B One-Step for all women of reproductive potential without a prescription

The U.S. Food and Drug Administration (FDA) announced Thursday it’s approval of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.

Plan B One-Step emergency contraceptive
Image/Video Screen Shot

This approval comes after the agency’s June 10th notification of a United States District Court judge in New York of its intent to comply with the court’s April 5, 2013 order instructing the FDA to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.

To comply, the FDA asked Teva Women’s Health, the manufacturer of Teva , to submit a supplemental application seeking approval of the one-pill product to be made available without any restrictions. The agency has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application.

Plan B One-Step was first approved in July 2009 for use without a prescription for women age 17 and older and as a prescription-only option for women younger than age 17. In April 2013, the product was approved for nonprescription use for women as young as 15. With this approval, the product is now available without a prescription for use by all women of reproductive potential.

“Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The federal agency says Plan B One-Step will not stop a pregnancy when a woman is already pregnant and there is no medical evidence that the product will harm a developing fetus.

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