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Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
• By Bridget Silverman

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

The label revisions for testosterone are the visible results of an extensive safety review. (Shutterstock)

The US Food and Drug Administration’s newly revised stand on testosterone labeling for cardiovascular risk is the visible tip of the metaphorical iceberg of years of effort that went into evaluating a potential safety issue with a widely used drug.

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