Reuters: Regulatory News: U.S. FDA expands "morning after" pill approval after court order

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U.S. FDA expands "morning after" pill approval after court order Jun 20th 2013, 22:38 June 20 | Thu Jun 20, 2013 6:38pm EDT June 20 (Reuters) - The U.S. Food and Drug Administration on Thursday expanded its approval of the so-called "morning after" contraceptive pill to include all women of child-bearing age to comply with an order from a U.S. District court. The FDA said the Plan B One-Step emergency contraceptive, which is sold by Teva Pharmaceutical Industries, would be made available as an over-the-counter (OTC) product without age or point-of-sale restrictions. Plan B One-Step is a single dose pill intended to reduce the chance of pregnancy following unprotected sex or suspected contraceptive failure, such as a broken condom. "Over-the-counter access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," Janet Woodcock, long-time director of the FDA's Center for Drug Evaluation and Research, said in a statement. The FDA initially objected to, and appealed, a court decision ordering it to remove age restrictions on the pill. Earlier this month, the agency notified a U.S. District Court judge in New York of its intent to comply with the court's April 5, order instructing it to make the emergency contraceptives available OTC without restrictions on age or point is sale, such as forcing women to ask pharmacists for the product. The "morning after" pill was originally approved in 2009 without a prescription for women age 17 and older and as a prescription-only option for women younger than 17. In April of this year, it was approved for nonprescription use for women as young as 15, but the court ordered age restrictions be removed for all women able to bear children. Link this Share this Digg this Email Reprints

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