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Merck & Co., Inc. (MRK) May Not Have Shown Women Can Safely Choose Drug


11/7/2012 8:04:05 AM

Merck & Co. (MRK) may not have shown that women can safely choose to use the company’s overactive-bladder medication Oxytrol without a doctor’s prescription, U.S. regulators said. Food and Drug Administration staff asked outside advisers to vote on whether Merck’s data supports that women can appropriately choose to use the patch in an over-the-counter setting. The FDA staff released its report today ahead of a Nov. 9 advisory panel meeting to discuss the drug, which Merck is seeking to make the first bladder treatment available without a prescription. Merck, the third-largest U.S. drugmaker by revenue, bought the rights to nonprescription Oxytrol from Watson Pharmaceuticals Inc. (WPI) The FDA is scheduled to decide on Merck’s Oxytrol by the end of January, said Edwin Hemwall, associate vice president of clinical research for prescription to over- the-counter switches at the Whitehouse Station, New Jersey-based company.

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