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OTC Monographs Face Obsolescence In Shadow Of NDA Products

 
• By Lisa Gillespie

Many monograph OTCs are overshadowed in the marketplace by NDA products and have much less space on store shelves. With some NDA-approved ingredients moved to monographs, FDA pre-market approval would no longer be required and more firms could make those products.

The OTC monograph system is at risk of obsolescence unless FDA moves some ingredients approved through new drug applications into monographs, which would expand competition for manufacturing those products, according to experts.

Many monograph OTCs largely are overshadowed and outsold in the marketplace by NDA products, either Rx-to-OTC switches or other drugs...

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