Mumbai, Mar 23: Pharma major, Glenmark Pharma on Thursday said it has received final approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%,0.064%, the generic version of Enstilar Foam,0.005%,0.064%, of Leo Pharma AS.
With respect to 180-day generic drug exclusivity, the FDA noted that Glenmark was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%.0.064%.
Therefore, with this approval, Glenmark is eligible for 180-days of generic drug exclusivity for Calcipotriene and Betamethasone Dipropionate Foam, 0.005%|0.064%.
According to IQVIATM sales data for the 12-month period ending January 2023, the Enstilar Foam, 0.005%,0.064% market achieved annual sales of approximately USD93.6 million. (UNI)
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