Glenmark Pharmaceuticals Ltd. on Tuesday announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Apremilast Tablets, 10 mg, 20 mg and 30 mg.
According to the company’s statement, it is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen Inc. It is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.
According to IQVIATM 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 authorized for distribution in the U.S. marketplace and 50 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
