Plan B as OTC for 17 year old women

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The Food and Drug Administration (FDA) announced that it will not appeal a U.S. District Court order that 17 year old girls should have unrestricted, over-the-counter access to Plan B or so-called “emergency contraception.”

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 US 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.

Plan B is the only FDA-approved emergency contraceptive currently available, composed of two (levonorgestrel, 0.75 mg) progestin-only tablets. It reduces the chance of pregnancy by up to 89% when taken as directed within 72 hours (3 days) after unprotected inter course, contraceptive failure. However, Plan B? is more effective the sooner it’s taken, especially within the first 24 hours.

Plan B is available behind the counter at pharmacies and sold under the supervision of pharmacy staff. A prescription would be needed only for women under 17 and younger.

Source: U.S. Food and Drug Administration, USA

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