Updated FDA Action on Plan B (levonorgestrel) Tablets
FDA News Release
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.
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Comment: Until now, the contraceptive product?which prevents pregnancy if taken within 72 hours of unprotected sex?was available only for those 18 and over who presented a valid ID to a pharmacist behind the counter. Younger teens needed a prescription to get access to it.
FDA News Release
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.
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Comment: Until now, the contraceptive product?which prevents pregnancy if taken within 72 hours of unprotected sex?was available only for those 18 and over who presented a valid ID to a pharmacist behind the counter. Younger teens needed a prescription to get access to it.