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Lupin receives tentative approval for Testosterone Gel, 1.62%

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From USFDA

announced that it has received tentative approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 gm actuation) from the 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 or absence of endogenous testosterone: (congenital or acquired) and (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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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, April 17 2018. 15:50 IST
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