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Axiron FDA Approval History

FDA Approved: Yes (Discontinued) (First approved November 23, 2010)
Brand name: Axiron
Generic name: testosterone
Dosage form: Topical Solution
Company: Eli Lilly and Company
Treatment for: Hypogonadism, Male

Marketing Status: Discontinued

Axiron (testosterone) is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

The FDA posted a notice regarding the discontinuation of manufacture of Axiron in September 2017. The product was not discontinued or withdrawn for safety or efficacy reasons.

Generic Axiron Availability

Development timeline for Axiron

Nov 24, 2010Approval Lilly and Acrux Receive FDA Approval for Axiron (Testosterone) Topical Solution CIII

Further information

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