Glenmark gets tentative nod from USFDA for generic psoriasis foam

The tentative approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by USFDA is for Calcipotriene and Betamethasone Dipropionate foam

Glenmark Pharmaceuticals on Monday said its US-based arm has received tentative approval from the US health regulator for its generic Calcipotriene and Betamethasone Dipropionate foam used to treat psoriasis.

The tentative approval granted to Glenmark Pharmaceuticals Inc, USA (Glenmark) by the US Food & Drug Administration (USFDA) is for Calcipotriene and Betamethasone Dipropionate foam of strength 0.005 per cent/0.064 per cent, the company said in a statement.

It is the generic equivalent of Leo Pharma AS' Enstilar foam, it added.

Citing IQVIATM sales data for the 12 months ended March 2022, the company said Enstilar foam, 0.005 per cent/0.064 per cent achieved annual sales of approximately USD 115.2 million.

 

Glenmark said its current portfolio consists of 174 products authorised for distribution in the US marketplace and 48 abbreviated new drug applications (ANDAs) are pending approval with the USFDA.