FDA Updates Testosterone Product Labeling: What Pharma Regulatory Teams Need to Know

FDA Announces Major Updates to Testosterone Product Labeling

The FDA has issued significant new labeling requirements for all testosterone products, following key findings from the TRAVERSE clinical trial and postmarket ambulatory blood pressure (ABPM) studies. These changes, effective in 2025, are aimed at improving patient safety and ensuring clear communication of risks for both healthcare providers and patients

Key Labeling Changes:

• TRAVERSE Trial Results: All testosterone product labels must now include results from the TRAVERSE trial, which assessed long-term cardiovascular outcomes in men with hypogonadism.
  
  

• Limitation of Use: The “Limitation of Use” language for age-related hypogonadism will remain, reinforcing that testosterone is only approved for men with specific medical conditions causing low testosterone, not for age-related decline alone.
  
  

• Boxed Warning Update: The previous Boxed Warning about increased risk of adverse cardiovascular outcomes is being removed, reflecting updated safety data.
  
  

• Blood Pressure Warnings: New, product-specific warnings about increased blood pressure are required. Products with completed ABPM studies must include detailed blood pressure risk information, while those without such warnings must add a general warning about this risk.

What does this mean for Regulatory Teams?

For pharmaceutical regulatory teams, these updates require:

• Immediate review and revision of all testosterone product labels to incorporate the new FDA-mandated language.
  
  

• Careful attention to ensure that blood pressure warnings are included appropriately, based on the latest ABPM study data for each product.
  
  

• Ongoing monitoring and compliance to avoid regulatory penalties or product approval delays
  
  

How Entvin’s AI Regulatory Tools Help

At Entvin (YC S22), our regulatory AI agents streamline this process by:

• Instantly generating side-by-side comparisons of competitor labels, highlighting differences and similarities in blood pressure warnings and other critical sections.
  
  

• Using AI-driven insights to spot labeling patterns and ensure your product language aligns with current FDA requirements.
  
  

• Suggesting compliant label language based on the latest approved references, reducing manual effort and risk of error.

Example: In a recent comparison of JATENZO, TESTIM, and NATESTO labels, our AI quickly identified that only JATENZO currently includes a blood pressure warning, while the others do not, highlighting immediate areas for compliance updates.

If you need detailed, side-by-side label comparisons or expert insights on compliance for any testosterone product, contact us directly for a personalized review.