Merck May Not Have Shown Women Can Safely Choose Drug
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Merck & Co., the third-largest U.S. drugmaker by revenue, may not have shown that women can safely use the company’s overactive-bladder medication Oxytrol without a doctor prescription, U.S. regulators said.
Food and Drug Administration staff asked advisers to vote on whether Merck’s data supports that women can appropriately 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.