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SEALD LABELING FINAL PI SIGNOFF REVIEW - accessdata fda

SEALD LABELING FINAL PI SIGNOFF REVIEW - accessdata fda 2025

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The document outlines the review process and findings related to the NDA 022504 for Axiron, a testosterone topical solution developed by Acrux Pharma Pty Ltd. It details the labeling reviews conducted by various FDA divisions, confirming that all critical prescribing information deficiencies have been addressed and that the labeling is ready for approval. The document includes evaluations of revised labels, recommendations for improvements to minimize medication errors, and compliance with regulatory standards. Additionally, it discusses the drug's indication for testosterone replacement therapy in hypogonadal males and highlights concerns regarding potential abuse and dependence associated with anabolic steroids.

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