 "Glenmark gets USFDA nod to market generic version of Otezla tablets")
Global pharmaceutical company Glenmark Pharmaceuticals announced on Tuesday that it has received final approval from the United States Food and Drug Administration (USFDA) for Apremilast Tablets, available in 10 mg, 20 mg, and 30 mg strengths. These tablets serve as the generic version of Amgen Inc.'s renowned Otezla.
Apremilast is a prescription medication used to treat plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet's disease.
According to IQVIA annual sales data, which ended in August 2023, Otezla Tablets in 10 mg, 20 mg, and 30 mg variants generated annual sales of approximately $3.7 billion.
Glenmark's current portfolio includes a total of 188 products that have been authorised for distribution in the U.S. marketplace. Additionally, they have 50 Abbreviated New Drug Applications (ANDAs) awaiting approval from the USFDA.
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