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Dual Rx/OTC Status In US ‘Additional Condition’ Switch Proposal: Necessary Or Questionable?

FDA Shift In Requirements For OTC Switch Follow-On Approvals Also Discussed By Experts

 
• By Malcolm Spicer

OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.

• Source: Shutterstock

A proposed US rule to facilitate OTC switches for chronic conditions would bend two basic rules of drug regulation, one keeping approvals of Rx and nonprescription drugs separate and the other setting approval requirements for follow-on generic equivalents of switched products.

Both pieces of the Food and Drug Administration’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use”

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