ARTICLE | Clinical News
FDA issues CRL for Antares' hypogonadism candidate
October 23, 2017 3:17 PM UTC
Antares Pharma Inc. (NASDAQ:ATRS) said FDA issued a complete response letter for Xyosted to treat hypogonadism.
The company said the CRL raised concerns over a clinically meaningful increase in blood pressure and the occurrence of depression and suicidality observed in the Phase III QST-13-003 and QST-15-005 trials of Xyosted in the indication. Antares said the letter cited no CMC, device or efficacy issues...
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