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news.Repros Therapeutics (Repros) has responded to the FDA as requested by the agency during the Type C meeting held on January 25, 2010. The company has sent a revised indication statement to the FDA’s Division of Reproductive and Urologic Products, for the use of Androxal in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state.
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The company has provided a literature review supporting it’s belief that administration of exogenous testosterone at doses resulting in morning testosterone levels within the normal range, render a significant number of men oligospermic.
Repros has also submitted the final clinical study report investigating the fertility impact of Androxal, compared to a topical testosterone in men previously treated with testosterone for hypogonadism. Previously, the company noted that the FDA suggested it will respond to Repros’ submission in a timely fashion following receipt of it’s materials.
Repros Therapeutics focuses on the development of oral small molecule drugs for the treatment of male and female reproductive disorders.