FDA seeks more safety data on Antares testosterone drug
(Reuters) – Antares Pharma Inc said the U.S. Food and Drug Administration has asked for additional safety data on its testosterone drug after a patient developed hives in a mid-stage trial. Antares' shares fell 7.6 pct in premarket trading on Tuesday on concerns that the regulator's request could delay the company's marketing application for the drug. The FDA has become more cautious about approving testosterone drugs after it found late last year that more than a fifth of the patients prescribed such drugs did not get their testosterone levels tested before or during treatment. …
