The “new paradigm” for OTC switches opening in the US with the Food and Drug Administration’s “additional conditions for nonprescription use” final rule published recently also brings new challenges for drug firms, the agency and the marketplace.
Revenue Drain Among Challenges For ACNU OTC Marketers From Simultaneous Rx Availability
Final rule’s requirement that ACNU formulations also remain available as Rx generics could limit revenues for marketers of the nonprescription drugs while approvals of ACNU applications from studies with participants having drugs delivered to their homes may require marketers to limit distribution to direct-to-consumer without clearance for sales in retail stores.
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