Glenmark Pharmaceuticals said Monday that its US unit had received preliminary approval from US health regulators for a generic calcipotriene and betamethasone dipropionate foam to treat psoriasis. In a statement, the company said the US Food and Drug Administration (USFDA) granted preliminary approval to Glenmark Pharmaceuticals Inc in the US for Calcipotriene and Betamethasone Dipropionate foams at 0.005%/0.064% concentrations.

It added that it is the generic equivalent of Leo Pharma AS’ Enstilar foam. Citing IQVIATM’s 12-month sales data through March 2022, the company said the 0.005%/0.064% Enstilar foam achieved annual sales of about $115.2 million.

Glenmark said its current product portfolio includes 174 products approved for distribution in the US market and 48 abbreviated new drug applications (ANDAs) pending approval by the USFDA.