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FDA requests more data on “Low T”

/ Dangerous Drugs /

FDA requests more data on "Low T"NEW YORK – The U.S. Food and Drug Administration is asking companies for more safety data on testosterone drugs after a patient broke out in hives during a mid-stage trial.

According to Reuters, the FDA is becoming more cautious with testosterone drugs since it discovered a large percentage of patients didn’t get their hormone levels tested before or during treatment.

Reuters reports the FDA requested data on 350 patients exposed to QuickShot Testosterone, a drug introduced by Antares Pharma Inc. The pharmaceutical company reports it may have to submit more data based on its ongoing late-stage trial.

Antares is currently in the testing phase of QuickShot Testosterone and the government’s request for more data could delay its regulatory and marketing applications.

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