FDA Grants Exclusive Rights to Morning-After Pill
Published: July 23, 2013
- The manufacturer of the best-known morning-after pill, Plan B One-Step, has been granted exclusive marketing rights for three years by the Food and Drug Administration. The decision means that the drug maker, Teva Pharmaceuticals, is — for now — the only company able to sell the drug over-the-counter and without a prescription for all ages. 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. Even if the approval is granted they would not be able to sell their products to those under 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 month to 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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