US FDA gives nod to Glenmark for skin ointment

Tacrolimus ointment is used for treating atopic dermatitis (eczema)

Glenmark Pharmaceuticals has received final approval from the US health regulator for Tacrolimus ointment used for treating atopic dermatitis (eczema). Glenmark Pharmaceuticals Inc USA has been granted final approval by the United States Food and Drug Administration (US FDA) for Tacrolimus ointment USP, 0.1 per cent, the company said in a BSE filing. The product is a generic version of Protopic ointment, of Leo Pharma AS in the same strength, it added.

According to IQVIA sales data for the 12-month period ending February 2018, Protopic ointment 0.1 per cent achieved annual sales of around $ 109 million, Glenmark Pharmaceuticals said. The company’s current portfolio consists of 132 products authorised for distribution in the US market and 61 Abbreviated New Drug Applications (ANDA’s) pending approval with the US FDA, it added.