Lupin gets US FDA nod to market testosterone gel

The product is a generic version of AbbVie’s AndroGel in the same strength

Lupin has received tentative nod from the US health regulator to market its Testosterone gel 1.62 per cent. The company has received tentative approval from the United States Food and Drug Administration (US FDA) to market its generic Testosterone Gel, 1.62 per cent, Lupin said in a statement. The product is a generic version of AbbVie’s AndroGel in the same strength, it added.

As per IQVIA MAT January 2018 data, Testosterone Gel 1.62 per cent had annual sales of around $ 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.