Lupin receives FDA approval for generic Axiron topical solution

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Pharma Major Lupin has received final approval for its Testosterone Topical Solution, 30 mg per actuation from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Axiron® Topical Solution, 30 mg per actuation.

Lupin’s Testosterone Topical Solution, 30 mg per actuation is therapeutically equivalent to Eli Lilly and Company’s Axiron® Topical Solution, 30 mg per actuation. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.

Testosterone Topical Solution, 30 mg per actuation, had annual sales of approximately USD 244.2 million in the US. (IMS MAT June 2017).