FDA to Approve Generics Based on Draft Labeling

The FDA’s Office of Generic Drugs (OGD) will no longer require final printed labeling to approve Abbreviated New Drug Applications (ANDAs).

Instead, the FDA will approve ANDAs on the basis of draft labeling, provided that the draft version enables OGD to conduct an appropriate review before a final printed label for a pending generic drug is produced.

In its new industry guidance, the FDA wrote that draft labeling to support ANDA approvals “should reflect the full content of the labeling as well as the planned ordering of the content of the labeling in order for OGD to make this determination.”

Previously, OGD required final printed labeling in order to approve ANDAs because it believed that final versions represented an “accurate presentation of the layout, print size, color, prominence, and readability.”

But the FDA noted that advancements have occurred in the ANDA labeling submission process, particularly with respect to electronic submission capabilities. With these advancements, the OGD can more accurately determine whether or not draft labeling confirms to applicable content and formatting requirements, the FDA stated.

OGD clarified that it will only approve ANDAs on the basis of draft labeling if deficiencies in the draft versions are “of an editorial or similarly minor nature.”

If a generic drug is approved based on draft labeling, then it is the applicant’s responsibility to ensure that the final printed label is identical to the draft label approved by FDA.

Failure to comply with this requirement could render the product misbranded and unapproved.

This industry guidance was immediately implemented without prior public comment because the FDA determined that such participation was not feasible or appropriate.

Guidance issued by the FDA is nonbinding.