Lupin receives FDA approval for Testosterone Gel
- Post By : Kumar Jeetendra
- Source: MBI
- Date: 11 April, 2019
Mumbai, Baltimore, April 11, 2019: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie, Inc’s (AbbVie) AndroGel 1.62%.
Lupin’s Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), is the generic equivalent of AbbVie’s AndroGel, 1.62%. 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% (20.25 mg/1.25 g pump actuation), (RLD: AndroGel) had annual sales of approximately USD 893 million in the US (IQVIA MAT December 2018).