Glenmark Pharma bags USFDA nod for generic version of Otezla Tablets

Mumbai: Glenmark Pharmaceuticals Ltd. has announced that the Company has received final approval from the United States Food & Drug Administration (U.S. FDA) for Apremilast Tablets, 10 mg, 20 mg and 30 mg used for the treatment of plaque psoriasis and oral ulcers.

A product is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of Amgen Inc.

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 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," The Company stated.

Read also: Submit Phase III CT Protocol: CDSCO Panel Tells Glenmark Pharmaceuticals on Antidiabetic FDC