[January 25, 2013]

FDA's Approval of First-in-Class Switch Empowers Consumers

Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville today issued the following statement regarding the Food and Drug Administration's approval of Merck's application to switch the overactive bladder treatment Oxytrol for Women^® to nonprescription sale:

"History has demonstrated time and time again that when the FDA approves an application to switch a product from prescription to nonprescription status, it is good news for consumers.It's good news because Rx-OTC switches empower consumers and make healthcare more accessible and affordable."

"This represents a brand-new category for nonprescription medicines that were formerly available only by prescription."

"When medicines switch from prescription to nonprescription status, consumers benefit from the expanded access and lower cost. Each year, 240 million people treat their symptoms with over-the-counter (OTC) medicines, bought off the shelf without a prescription. An estimated 60 million of these consumers would not otherwise seek treatment. Previous prescription to OTC switches have empowered consumers to conveniently buy and use antihistamines, pain relievers, heartburn reducers, nicotine replacement therapies, vaginal yeast infection treatments, and more without having to go to the doctor. Today's consumers are taking more control of their healthcare needs, and the FDA's decision to enhance self-care for women with overactive bladder is a step in the right direction."

CHPA is the 132-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and dietary supplements.

chpa-info.org

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