01
Approved indication
A growth hormone releasing factor analogue approved by the FDA in November 2010 as Egrifta, for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy. Regulatory review documents set the indication out narrowly: excess visceral adipose tissue assessed by waist circumference at or above 95 cm in men and 94 cm in women and confirmed above 130 cm2 by computed tomography, in treatment-experienced adults, limited to those who did not reduce that tissue through diet and exercise, at 2 mg subcutaneously once daily.


Leave a researcher note