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Pharmaceuticals / Regulatory Affairs

FDA Approves Clarus’ Testosterone Pill on Second Attempt

April 4, 2019
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The second time proved a charm for Clarus Therapeutics as the FDA has approved the Northbrook, Ill.-based drugmaker’s testosterone pill Jatenzo for hypergonadism.

Jatenzo (testosterone undecanoate) was the subject of a complete response letter and the company resubmitted the drug for approval in 2017, relying on Phase III data showing that 87 percent of men were able to raise their testosterone levels back to the normal range.

The FDA will require a black box label to warn patients of the risk of high blood pressure and an increase in the risk of heart attack and other side effects. There are also risks of elevated prostate specific antigen levels, the agency said.

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