US Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches

Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.

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The “additional conditions for nonprescription use” proposed rule on facilitating OTC switches in the US reminds the Consumer Healthcare Products Association of marketplace problems for two of the most recent drugs made available nonprescription.

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