Glenmark Pharma gets USFDA nod for two drugs

The drug maker said that it has received final approval from US Food & Drug Administration (USFDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%, 0.064%.

The said drug is a generic equivalent of Enstilar Foam, 0.005%, 0.064%, of Leo Pharma AS. It is used to treat psoriasis. It helps to reduce the redness, thickening, and scaling of the skin that occurs with this condition.

With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was the first abbreviated new drug application (ANDA) applicant to submit a substantially complete ANDA with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%, 0.064%. Therefore, Glenmark is eligible for 180-days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%, 0.064%.

According to IQVIA sales data for the 12-month period ending January 2023, the Enstilar Foam, 0.005%