Potential Indication for Testosterone Replacement Therapy
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The FDA is considering expanding testosterone replacement therapy (TRT) to treat low libido in men suffering from idiopathic hypogonadism, a condition with no known cause. They invite companies with approved TRT drugs to seek additional approval for this use by submitting further evidence by April 2026.
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Key Changes
- Recognition of potential new use for testosterone replacement therapy
- Call for additional approval applications for treating low libido linked to idiopathic hypogonadism
- Deadline set for supplementary data submission by April 2026
Obligations
What this law requires
Holders of currently approved testosterone replacement therapy (TRT) new drug applications (NDAs) must submit a supplemental NDA for the new indication to treat low libido in men with idiopathic hypogonadism.
Companies must contact the FDA for further information regarding the submission of the supplemental NDA, including data needed to support the new indication.
Submissions must be supported by rigorous scientific evidence and comprehensive risk-benefit analysis, consistent with applicable law.