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20 April, 2024 19:10 IST
Lupin gets tentative USFDA approval for Testosterone gel
Source: IRIS | 17 Apr, 2018, 04.06PM
Rating: NAN / 5 stars.
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Pharma major 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).

Shares of the company gained Rs 22.95, or 2.94%, to settle at Rs 804.30. The total volume of shares traded was 128,567 at the BSE (Tuesday).

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