The Food and Drug Administration has granted Lupin tentative approval for its generic AndroGel (testosterone gel, 1.62%). The drug is indicated as a replacement therapy in males for conditions associated with deficiency or absence of endogenous testosterone.

Lupin’s generic AndroGel will be available in a dosage strength of a 20.25 mg/1.25 gm actuation. The drug had U.S. sales of $956.9 million for the 12 months ended January 2018.