Posted from: Friday, October 30, 2015 - 12:25 PM - Present

First Generic to Valeant

September 21, 2015 – The U.S. Food and Drug Administration (FDA) granted approval to the first generic to Valeant’s Testred (methyltestosterone) 10mg capsule. Methyltestosterone as a synthetic androgen used for primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired) in men. Methyltestosterone is also indicated to stimulate puberty in carefully selected males with clearly delayed puberty, and secondarily in women with advancing inoperable metastatic mammary cancer. Testred was originally approved by the FDA on December 3, 1973. Dosing for Methyltestosterone varies depending on age, sex, and diagnosis of individual patient; and could be adjusted according to the patient’s response and appearance of adverse reactions. According to the Drug Enforcement Agency (DEA), Methyltestosterone is classified as a Schedule III drug.

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Last Updated Wednesday, July 26, 2017 - 10:47 PM.