FDA Finalizes Aspirin Labeling Guidance for Products with Cardiovascular Imagery

08/11/17

Event Title

08h00 - 16h30

Event Location

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On November 7, 2017, the U.S. Food and Drug Administration (FDA) finalized the guidance document, Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled with Cardiovascular Related Imagery. 


The final guidance applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid product types. If a product includes cardiovascular related imagery, the FDA does not intend to take action if the following statement were in close proximity, “Talk to your doctor or other healthcare provider before using this product for your heart.” The statement shall be in similar prominence and at least 6 point type size on the PDP.


It should be noted that the wording of the final guidance statement varies slightly from that in the draft guidance.


Click to view the final guidance:

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm536506.pdf


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