Lupin gets USFDA nod to market gel that treats low testosterone in men
The company's product is a generic version of AbbVie Inc's AndroGel 1.62 per cent, it added.
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The company's product is a generic version of AbbVie Inc's AndroGel 1.62 per cent, it added.
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Drug firm Lupin Thursday said it has received nod from the US health regulator to market its testosterone gel used for treating low or no testosterone in men due to certain medical conditions.
The company has received approval from the United States Food and Drug Administration (USFDA) to market its generic testosterone gel, 1.62 per cent (20.25 mg/1.25 g pump actuation), Lupin said in a statement.
The company's product is a generic version of AbbVie Inc's AndroGel 1.62 per cent, it added.
As per IQVIA MAT December 2018 data, AndroGel had annual sales of around USD 893 million in the US market, Lupin said.
The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
Shares of Lupin were trading at Rs 807.30 per scrip on BSE, up 0.42 per cent from the previous close.
First Published: Apr 11 2019 | 1:10 PM IST