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FDA review panel reports on low testosterone therapies.

Read time: 1 mins
Last updated: 18th Sep 2014
Published: 18th Sep 2014
Source: Pharmawand

An advisory panel to the FDA concluded in a vote 20-1 that Testosterone Replacement Therapies should be reserved for men with specific medical conditions that impair function of the testicles. The drug authorisation should be restricted to to people with medically related low testosterone, such as a genetic disorder or a tumour. The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone. The review is in response to the enormous rise in prescriptions for "Low T," ( low testosterone) for men with lowered testosterone levels caused by advancing age.

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