Drug-maker Glenmark Pharmaceuticals’ Apremilast Tablets, 10 mg, 20 mg and 30 mg, a generic version of Amgen’s Otezla Tablets, 10 mg, 20 mg and 30 mg, has received final approval from the United States Food and Drug Administration (U.S. FDA).
Otezla Tablets brand and therapeutic equivalents achieved annual sales of around $3.7 billion, Glenmark said citing IQVIA sales data for the 12-month period ending August 2023.
A phosphodiesterase 4 (PDE4) inhibitor, Apremilast is indicated for treating psoriatic arthritis plaque psoriasis and Behcet disease associated with oral ulcers.
Glenmark said its portfolio consists of 188 products authorised for distribution in the U.S. market while 50 abbreviated new drug applications (ANDAs) are pending approval with the U.S. FDA. It also continued to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
