fda-approval-letter
PHARMACY

FDA clears Clarus Therapeutics’ Jatenzo

BY Sandra Levy

The Food and Drug Administration has cleared Clarus Therapeutics’ branded product, Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism.

These men have low testosterone levels due to specific medical conditions, such as genetic disorders like Klinefelter syndrome or tumors that have damaged the pituitary gland.

“Jatenzo’s oral route of administration provides an important addition to current treatment options available for men with certain hypogonadal conditions who up until now have most commonly been treated with testosterone products that are applied to the skin or injected,” director of the division of bone, reproductive and urologic products in the FDA’s Center for Drug Evaluation and Research Hylton Joffe said.

“But it’s important to emphasize that this drug should not, like other testosterone treatments, be used to treat older men with ‘age-related hypogonadism.’ The benefits of testosterone therapy, including Jatenzo, have not been established for this use, and Jatenzo’s effects on raising blood pressure can increase the risks of heart attack, stroke and cardiovascular death in this population,” said Joffe.

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