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FDA近日批准Abbott公司AndroGel(tes-tosterone凝胶)1.62%用于治疗成人男性性腺功能减退。本品为澄清、无味凝胶制剂,与已批准的AndroGel 1%相比,仅需一半体积的凝胶即可恢复性腺功能减退的成人男性的睾酮水平。该新剂型的批准主要基于一项分为两期、历时364 d的对照
FDA recently approved Abbott Corp. AndroGel (tes-tosterone gel) 1.62% for the treatment of hypogonadism in adults. This product is a clear, odorless gel formulation that regains testosterone levels in hypogonadal adults with only half the volume of gel compared to approved AndroGel 1%. The approval of this new dosage form is based on a control period of 364 days divided into two phases