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Jatenzo FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 6, 2019.

FDA Approved: Yes (First approved March 27, 2019)
Brand name: Jatenzo
Generic name: testosterone undecanoate
Dosage form: Capsules
Company: Clarus Therapeutics, Inc.
Treatment for: Hypogonadism, Male

Jatenzo (testosterone undecanoate) is an oral testosterone replacement therapy for the treatment of low testosterone in hypogonadal men.

Development timeline for Jatenzo

DateArticle
Mar 27, 2019Approval FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
Jun 26, 2017Clarus Re-submits Jatenzo NDA Following Positive Results of inTUne Trial
Jan 13, 2014Clarus Therapeutics Submits New Drug Application for Rextoro (formerly CLR-610) for the treatment of Low Testosterone

Further information

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