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Updated FDA Action on Levonorgestrel Tablets

April 23, 2009 -- On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.

Plan B is manufactured by Duramed Research, Inc. of Bala Cynwyd, Pa.

Source: Food and Drug Administration

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