Issue Date: July 18, 2016
FDA offers guidance for updating generic drug labels
FDA has issued draft guidance detailing when drug companies should update the label for the generic version of a brand-name drug that has been taken off the market for reasons other than safety or effectiveness. Generic drugs are required to have the same labeling as their brand-name counterparts at the time of their approval. But FDA notes that there has been confusion about the process for updating a generic’s labels when the reference drug has been removed from the market for economic reasons. When new information becomes available that causes labeling to become inaccurate, FDA says generic drug makers should submit label updates to the agency. If FDA decides the change is warranted, it can request other companies that rely on the same withdrawn product make the same updates. “This latter step is intended to ensure that labeling remains uniform across generic drugs that rely on the same reference product,” FDA says. An example, the draft guidance says, would be to update the “warnings and precautions” section of the label if that information becomes outdated.
- Chemical & Engineering News
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