BioCentury
ARTICLE | Clinical News

QuickShot Testosterone regulatory update

January 26, 2015 8:00 AM UTC

FDA told Antares to expand its safety database for QuickShot Testosterone, which is in Phase III testing to treat hypogonadism. Antares said the request was based on a single reported occurrence of hives in a Phase II trial of the compound as well as known safety experience with other parenteral testosterone products. Antares said it does not believe the case of hives was related to the self-injectable formulation of testosterone enanthate delivered using Antares’ Vibex autoinjector technology. ...