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FDA grants Plan B exclusive marketing rights

The Food and Drug Administration on Tuesday granted Teva Pharmaceuticals, the manufacturer of Plan B One-Step, exclusive marketing rights for the next three years, meaning there will be no low-cost, generic versions of levonorgestrel-based emergency contraceptives available over-the-counter until 2016.

More from the New York Times on the decision:

Manufacturers of generic versions of the pill can apply to the F.D.A. for permission to sell their versions in drugstore aisles, instead of behind a pharmacy counter, but will have to continue requiring a prescription for those under age 17 until the three-year exclusivity period for Plan B One-Step ends.

Plan B One-Step retails for about $50; generics sell for at least $10 or $15 less. The F.D.A. decision Monday night follows the government’s decision last monthto comply with a federal court order to lift age and sale restrictions on Plan B One-Step, which had been available without a prescription only for ages 17 and older.

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