Module 6

04/10/2024

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USA – Switch applications



FULL SWITCH

 A sponsor switches the drug product covered under the NDA to nonprescription marketing status in its entirety.  Sponsor submits an efficacy supplement to an approved NDA or a 505(b)(2) application.

 The drug is then only available as a nonprescription drug.

The Organisation for Professionals in Regulatory Affairs

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USA – Switch applications



PARTIAL SWITCH

 A sponsor partially switches some of the conditions of use (e.g. indications) to nonprescription marketing status, while retaining others within a prescription status.

Sponsor submits a new NDA.

The drug is then available:  as a prescription drug for certain conditions and  a nonprescription drug for other conditions

The Organisation for Professionals in Regulatory Affairs

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