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FDA OKs Single-Dose Plan B Emergency Contraceptive

Posted 3+ months ago by Drugs.com

MONDAY, July 13 – A single-pill version of the Plan B emergency contraceptive has been approved by the U.S. Food and Drug Administration. The drug previously was available in a two-pill dose.

The new Plan B One-Step will be available at pharmacies in August, Teva Pharmaceutical Industries Ltd. said Monday.

The FDA also said it expanded over-the-counter access to Plan B One-Step to consumers over 17 years old, while those younger than 17 will require a prescription. Previously, OTC sales were limited to women aged 18 and older. Read more...

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FDA Approves 'Plan B' Pill for 17-Year-Olds

Posted 3+ months ago by Drugs.com

WEDNESDAY, April 22 – Responding to a federal judge's directive, the U.S. Food and Drug Administration said Wednesday that it will now allow 17-year-olds to get the controversial "morning-after" birth control pill without a doctor's prescription.

In 2006, the FDA said it would limit over-the-counter access to the pill, also known as Plan B, to women 18 and older. But U.S. District Judge Edward R. Korman ruled last month in a New York lawsuit that the FDA had to reconsider whether to make the drug available to all women, regardless of age, without a prescription. He ordered the agency to let 17-year-olds get the drug, and separately to evaluate whether all age restrictions should be lifted. Read more...

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Plan B, levonorgestrel, Preven EC, ethinyl estradiol/levonorgestrel