Lupin gets tentative USFDA approval for Testosterone gel

Mumbai, April 21, 2018: Pharma major Lupin on Wednesday said that it has received tentative approval for its Testosterone Gel, 1.62 per cent (20.25 mg/1.25 gm actuation) from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie Inc.’s AndraGel, 1.62 per cent.

Lupin’s Testosterone Gel, 1.62 percent (20.25 mg/1.25 gm actuation) is the generic equivalent of AbbVie AndraGel Inc.’s AndroGel, 1.62 per cent. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).

Testosterone Gel, 1.62 percent (20.25 mg/1.25 gm actuation) had annual sales of approximate USD 956.9 million in the US (IQVIA MAT January 2018).

United News of India