Morning-after Pill for Girls 15 and Older – FDA Approved

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The U.S. Food and Drug Administration announced Tuesday that it approved the availability of the Plan B One-Step emergency contraception pill without a prescription for women 15 and older.

This move comes just weeks after a federal judge in Brooklyn, New York, ordered the FDA to make the morning-after birth control pill available to women of any age, without a prescription.

Tuesday’s FDA announcement, which pertains to an application from Teva Women’s Health, Inc., is not related to that, the FDA said.

“The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling,” the FDA said in a statement.

In early April, the U.S. Justice Department indicated an appeal of the Brooklyn judge’s order was under consideration. “The Department of Justice is reviewing the appellate options and expects to act promptly,” department spokeswoman Allison Price said.

According to the new FDA decision, Plan B One-Step will now be labeled to reflect that proof of age is required to purchase it, and it cannot be sold where age cannot be verified. The packaging will include a product code that prompts the cashier to ask and verify the age of the customer.

The product will be available in retail outlets with pharmacies, but the pill can be sold during non-pharmacy hours,

h/t – CNN

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