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Kyzatrex FDA Approval Status

Last updated by Judith Stewart, BPharm on Jan 20, 2021.

FDA Approved: No
Brand name: Kyzatrex
Generic name: testosterone undecanoate
Company: Marius Pharmaceuticals
Treatment for: Hypogonadism, Male

Kyzatrex (testosterone undecanoate) is a novel, soft gelatin capsule testosterone formulation in development for the treatment of primary and secondary hypogonadism in adult men.

Development Timeline for Kyzatrex

Mar 11, 2021Marius Pharmaceuticals Receives PDUFA Date for Kyzatrex NDA for Treatment of Hypogonadism
Jan  5, 2021Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism

Further information

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