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The US FDA grants approval for new oral testosterone capsule for treating certain forms of hypogonadism in men.

M2 PHARMA-March 28, 2019-The US FDA grants approval for new oral testosterone capsule for treating certain forms of hypogonadism in men

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Public health company The US Food and Drug Administration on Wednesday authorised the marketing of the oral testosterone Jatenzo (testosterone undecanoate) capsule for the treatment of men with certain forms of hypogonadism.

This US FDA's approval of Jatenzo was awarded to Clarus Therapeutics.

The agency added that the men have low testosterone levels due to specific medical conditions and genetic disorders including Klinefelter syndrome or tumors that have damaged the pituitary gland.

In conjunction, the efficacy of Jatenzo was demonstrated in the company's four-month clinical trial involving 166 men with hypogonadism. Study participants initially were given Jatenzo at a dose of 237mg twice per day and the dose was adjusted downward or upward to a maximum of 396mg twice per day on the basis of testosterone levels. About 87% percent of Jatenzo-treated men achieved an average testosterone level within the normal range, which was the primary study endpoint.

Currently, Jatenzo is one of two testosterone products that have this boxed warning. All testosterone product manufacturers have to conduct blood pressure postmarketing trials to more clearly address whether these products increase blood pressure, concluded the agency.

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Publication:M2 Pharma
Date:Mar 28, 2019
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