Potential New Indication for Testosterone Replacement Therapy
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have reviewed information in published literature that seems promising regarding the potential use of testosterone replacement therapy (TRT) in the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism. We encourage holders of approved TRT new drug applications (NDAs) that are interested in seeking approval for this new indication to contact FDA for further information regarding submission of a supplemental NDA, including data needed to support an approval.
Abstract as published in the Federal Register.
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