Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry

Issue Date: October 7, 2015
Issued by: Center for Drug Evaluation and Research
Topic(s): Generic Drugs
Status: Draft

Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry

This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs) under section 505(j)(2)(A)(v) of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s implementing regulations (21 CFR 314.94(a)(8)). This guidance is intended to assist applicants submitting ANDAs under section 505(j) of the Act to the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). It explains FDA’s interpretation of the regulatory provision related to the submission of copies of applicants’ proposed labeling in ANDAs and clarifies that OGD will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.

Download the Guidance Document