A U.S. court dismissed on Tuesday a lawsuit against U.S. health regulators over their decision to allow the sale of Barr Pharmaceuticals Inc Plan B contraceptive without a prescription.
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The U.S. Food and Drug Administration and Barr were sued by the Association of American Physicians and Surgeons and other groups that sought to overturn the FDA's decision.
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The U.S. District Court for the District of Columbia granted FDA's and Barr's motion to dismiss the suit.
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The court said it agreed with defendants that plaintiffs failed had to identify a single individual who has been harmed by Plan B's OTC (over-the-counter) availability, according to the ruling.
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Plan B was approved in 1999 and the FDA broadened the approval in 2006 to allow sale to adults without a prescription. The pills must be kept behind pharmacy counters and only sold to girls younger than 18 years old with a doctor's order.
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Separately, on Monday, another U.S. court found the patent for Bayer AG's Yasmin contraceptive drug to be invalid, paving the way for Barr to sell a generic version.
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It's a big win for Barr, Natixis Bleichroeder analyst Corey Davis said of the Bayer ruling. This could be one of those nice generic products with a long tail on it, he said./div |
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