Federal Register #2026-07615

FDA Notice: New Indication for TRT and Draft Guidance on Respirators

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking engagement from industry regarding two regulatory initiatives: - Testosterone Replacement Therapy (TRT) New Indication: - FDA invites holders of approved TRT New Drug Applications (NDAs) to pursue a new indication for treating low libido in men with idiopathic hypogonadism - Interested NDA holders should contact FDA for guidance on submitting a supplemental NDA - Approval will require robust scientific evidence and a comprehensive risk-benefit analysis - No specific OEMs or vendors are named; the notice is directed at current NDA holders for FDA-approved TRT products - NIOSH-Approved Air-Purifying Respirators Draft Guidance: - FDA released draft compliance policy for certain NIOSH-approved air-purifying respirators, including surgical N95s, reusable respirators, and powered air-purifying respirators (PAPRs) - Public comments are invited on the draft guidance - Products/Services Mentioned: - Testosterone Replacement Therapy (TRT) drug products (no part numbers or quantities specified) - NIOSH-approved air-purifying respirators (surgical N95s, N95 FFRs, PAPRs, elastomeric half/full facepiece respirators) - Notable Requirements: - Engagement is limited to current NDA holders for TRT products - Scientific rigor and risk-benefit analysis are emphasized for new indication approval - Public comment period for respirator guidance - Government Buyer: - Food and Drug Administration, Center for Drug Evaluation and Research

Description

The Food and Drug Administration (FDA) has reviewed published literature suggesting that testosterone replacement therapy (TRT) may be effective in treating low libido in men with decreased libido associated with idiopathic hypogonadism. The FDA is encouraging holders of approved TRT new drug applications (NDAs) interested in seeking approval for this new indication to contact the agency for guidance on submitting a supplemental NDA. The notice outlines the preliminary findings and invites NDA holders to engage with the FDA by April 30, 2026, to discuss data requirements and approval processes.

View original listing