Lupin receives FDA approval for Testosterone Gel

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).

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