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Oxytrol Switch Should Hinge On Symptom ID, Not Diagnosis – Merck Consultant

 
• By Dan Schiff

Merck’s proposed Rx-to-OTC switch of Oxytrol for Women is about identifying symptoms of overactive bladder, not diagnosing the condition, says Eric Brass, former chair of FDA’s Nonprescription Drugs Advisory Committee. Several NDAC members Nov. 9 insisted OAB should be diagnosed before treatment.

The recent meeting of an FDA advisory panel – heavy on temporary members with limited experience in Rx-to-OTC switch – reviewing Merck & Co. Inc.’s proposed switch of Oxytrol for Women should have focused more on consumers’ ability to recognize the symptoms of overactive bladder rather than whether they can self-diagnose OAB, a Merck consultant and former chairman of the advisory committee says.

FDA had tasked the Nonprescription Drugs Advisory Committee at the Nov

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