Glenmark gets FDA nod to mkt generic diabetes drug
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NEW DELHI: Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. The company has received final approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets (2.5 mg and 5 mg), the generic version of AstraZeneca's Onglyza1 tablets, the Mumbai-based drug maker said in a statement. According to IQVIATM sales data, for the 12-month period ending June 2023, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 100.7 million. Glenmark said its current portfolio now consists of 184 products authorized for distribution in the US market and 49 abbreviated new drug applications (ANDAs) are pending approval with the US FDA.