Mumbai: Drug firm Lupin said it has received the tentative nod from the US health regulator to market its Testosterone gel 1.62 percent.
The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market its generic Testosterone Gel, 1.62 percent, Lupin said in a statement.
The product is a generic version of AbbVie Inc’s AndroGel in the same strength, it added.
As per IQVIA MAT January 2018 data, Testosterone Gel 1.62 percent had annual sales of around USD 956.9 million in the US, Lupin said.
The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, it added.