Glenmark Pharma gets ANDA nod for Apremilast Tablets, 10 mg, 20 mg and 30 mg

Apremilast Tablets, 10 mg, 20 mg and 30 mg, is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen

Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Apremilast Tablets, 10 mg, 20 mg and 30 mg, the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen.

According to IQVIA sales data for the 12-month period ending August 2023, the Otezla Tablets, 10 mg, 20 mg, and 30 mg market achieved annual sales of approximately $3.7 billion*.

Glenmark’s current portfolio consists of 188 products authorised for distribution in the US marketplace and 50 ANDAs pending approval with the US FDA.

ANDA approvalApremilast TabletsGlenmark PharmaceuticalsOtezla TabletsUS FDA
Comments (0)
Add Comment