Lupin gets US FDA approval for testosterone topical solution

The approved product is a generic version of Eli Lilly and Company’s Axiron topical solution

Drug firm Lupin has received the final approval from the US health regulator for its testosterone topical solution.

The company has received final approval for its testosterone topical solution, 30 mg per actuation from the United States Food and Drug Administration (US FDA) to market the product, Lupin said in a BSE filing.

The approved product is a generic version of Eli Lilly and Company’s Axiron topical solution, it added.

According to IMS MAT June 2017 data, testosterone topical solution had sales of $244.2 million in the US, Lupin said.

The testosterone topical solution is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone, it added.