Glenmark receives ANDA approval for Deferasirox Tablets for Oral Suspension
Glenmark Pharmaceuticals, USA has been granted final approval by the United States Food and Drug Administration (US FDA) for Deferasirox Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, the generic version of Exjade Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.
According to IQVIATM sales data for the 12‐month period ending November 2019, the Exjade Tablets for Oral Suspension, 125 mg, 250 mg and 500 mg market achieved annual sales of approximately $106.4 million.
Glenmark’s current portfolio consists of 165 products authorized for distribution in the US marketplace and 43 ANDA’s pending approval with the US 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.