Pharmaceutical Business review

Repros Responds To FDA On Androxal

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.