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New MAPP 5200.11: Prescription to Nonprescription Switches and Abbreviated New Drug Applications
On December 8, 2025, FDA published Manual of Policies and Procedures (MAPP), “Prescription to Nonprescription Switches and Abbreviated New Drug Applications.” This MAPP describes the policies and procedures for FDA’s Office of Generic Drugs (OGD) when a reference listed drug (RLD) switches from prescription to nonprescription marketing status. More specifically, this MAPP describes the procedures for OGD to send notifications to approved abbreviated new drug application (ANDA) holders regarding the need to submit additional information, including updated labeling for the ANDA for prescription-to-nonprescription switches.
This MAPP applies to full prescription-to-nonprescription switches after FDA has determined that there is no clinically meaningful difference between the generic drug product that is the subject of an approved ANDA and a drug product that was switched to nonprescription status under an approved new drug application. This MAPP does not apply to partial prescription-to-nonprescription switches or unapproved ANDAs. It is the ANDA holder’s responsibility to monitor for RLD changes and to submit additional information, including revised ANDA labeling to FDA in a timely fashion; however, as described in the MAPP, OGD intends to notify approved ANDA holders of the new drug application’s full prescription-to-nonprescription switch to help ensure that prescription and nonprescription versions of the same drug product that do not have a clinically meaningful difference are not marketed at the same time. In short, the procedures described in the MAPP include the OGD Office of Regulatory Operations, Division of Labeling Review (DLR) notifying approved ANDAs of the need to take appropriate steps regarding their application following a full prescription-to-nonprescription switch, tracking applicant responses, sending a follow-up notification if the ANDA holder does not address the prescription-to-nonprescription switch within six months of the first notification, and discussing potential next steps with the Center for Drug Evaluation and Research’s Office of Compliance and other applicable FDA offices if the ANDA holder does not respond within 30 days of the follow-up notification.
FDA issued this MAPP as part of efforts to help ensure access to safe, high-quality, effective generic nonprescription products after the new drug application product switches to nonprescription marketing status.
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