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Glenmark Pharma receives ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam

Glenmark Pharma receives ANDA approval for Calcipotriene and Betamethasone Dipropionate Foam

Mumbai, Mar 23 (UNI) 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 JS SY

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