BRIEF—FDA revises guidance on labeling following changes to reference drug

The US Food and Drug Administration (FDA) has published a revision to its Manual of Policies and Procedures (MAPP), Generic Drug Labeling Revisions Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

The MAPP lists the criteria for FDA approval of an abbreviated new drug application (ANDA) even though certain changes have been made to the labeling for the reference listed drug (RLD), as described under section 505(j)(10) of the FD&C Act.

This document also outlines the internal FDA process for managing these labeling changes, including the roles and responsibilities of Office of Generic Drugs (OGD) staff.

The OGD’s policies and procedures for implementing section 505(j)(10) of the FD&C Act, which permits the FDA to approve an ANDA, even if the ANDA approval coincides with certain changes approved by FDA to the labeling for the RLD, are described in this MAPP.

This provision has been implemented by the FDA by requesting that an ANDA applicant who is otherwise eligible for approval agree, in a letter of commitment, to submit revised labeling for its proposed generic drug product corresponding to the RLD labeling changes within a specified timeframe.

The revised MAPP clarifies that the agreement to submit revised labeling after approval under the provisions of 505(j)(10) is a statutory requirement, now defined as a Post-Approval Labeling Requirement.