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FDA approves Plan B One-Step OTC for all ages


 

The Food and Drug Administration approved the emergency contraceptive Plan B One-Step for over-the-counter sale for women and girls of all ages, ending years of litigation over the drug’s status.

On June 20, the FDA complied with an order from the U.S. District Court in New York and approved the one-pill levonorgestrel product with no point-of-sale restrictions. The drug was originally approved without a prescription for women aged 17 and older in 2009. Earlier this year, the agency granted nonprescription sale for women aged 15 and older. This latest approval will make the drug available to all women of childbearing age.

While reproductive rights advocates praised the Obama administration’s decision not to continue fighting greater access to emergency contraception in the courts, they urged the FDA to approve lower-cost generic options for over-the-counter sale.

mschneider@frontlinemedcom.com

On Twitter @MaryEllenNY

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