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.
- Jatenzo capsules are taken twice daily with food.
- The Jatenzo product label contains a boxed warning stating that the drug can cause blood pressure to rise, increasing the risk of heart attack, stroke and cardiovascular death. Healthcare providers should consider a patient’s individual heart disease risks and ensure that blood pressure is adequately controlled before prescribing Jatenzo; they should also periodically monitor patient blood pressure during treatment.
- Common adverse reactions include polycythemia, diarrhea, dyspepsia, eructation, peripheral edema, nausea, increased hematocrit, headache, prostatomegaly, and hypertension.
Development Timeline for Jatenzo
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