Lupin gets USFDA nod to market testosterone gel

Drug firm Lupin said it has received nod from the U.S 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 U.S market, Lupin said.

The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.