USFDA gives approval for Saxagliptin Tablets

Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the US by Glenmark Pharma, USA.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 24, 2023 by The Health Master

Glenmark Pharma has received final approval by the United States Food & Drug Administration (USFDA) for Saxagliptin Tablets, 2.5 mg and 5 mg, the generic version of Onglyza Tablets, 2.5 mg and 5 mg, of AstraZeneca AB.

Glenmark’s Saxagliptin Tablets, 2.5 mg and 5 mg, will be distributed in the US by Glenmark Pharma, USA.

According to IQVIA sales data for the 12‐month period ending June 2023, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately $100.7 million.

Glenmark’s current portfolio consists of 184 products authorised for distribution in the US marketplace and 49 ANDAs pending approval with the USFDA.

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