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Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch

 
• By Dan Schiff

FDA approved Merck’s overactive bladder drug Oxytrol for Women for OTC use, despite concerns raised by the Nonprescription Drug Advisory Committee in November. The company plans a launch in the fall.

FDA approved Merck & Co. Inc.’s Rx-to-OTC switch application for overactive bladder drug Oxytrol for Women, marking the first successful first-in-class switch since alli for weight loss in 2007.

Notably, the agency was not swayed by a Nonprescription Drugs Advisory Committee that voted 6-5 to say Merck had not shown consumers can safely self-select Oxytrol

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