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Kyzatrex FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 3, 2022.

FDA Approved: Yes (First approved July 27, 2022)
Brand name: Kyzatrex
Generic name: testosterone undecanoate
Dosage form: Capsules
Company: Marius Pharmaceuticals
Treatment for: Hypogonadism, Male

Kyzatrex (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism.



Development timeline for Kyzatrex

Jan  9, 2024Marius Pharmaceuticals Announces Pilot Study Exploring the Effect of Its Oral Testosterone Therapy, KYZATREX on Male Fertility
Aug  2, 2022Approval FDA Approves Kyzatrex (testosterone undecanoate) for the Treatment of Male Hypogonadism
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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