Glenmark gets USFDA nod for generic Tacrolimus ointment

Glenmark gets USFDA nod for generic Tacrolimus ointment

Glenmark Pharmaceuticals Ltd on Thursday said it has received approval from the US health regulator for its generic Tacrolimus ointment indicated for the treatment of moderate to severe atopic dermatitis.

The approval granted by the US Food & Drug Administration (USFDA) is for Tacrolimus ointment, 0.03 per cent, the generic version of Protopic Ointment, 0.03 per cent of Leo Pharma AS, the company said in a statement.

Glenmark's Tacrolimus ointment, 0.03 per cent, will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, it added.

The Protopic Ointment, 0.03 per cent market (brand and all available therapeutic equivalents), achieved annual sales of approximately USD 15.4 million, the company said citing IQVIA sales data for the 12-month period ending June 2023.