Lupin receives tentative approval for Testosterone Gel, 1.62%

From USFDA

Lupin announced that it has received tentative approval for its Testosterone Gel, 1.62% (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%.

Lupin's Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) is the generic equivalent of AbbVie Inc.'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 gm actuation) had annual sales of approximate USD 956.9 million in the US (IQVIA MAT January 2018).

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