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Glenmark has received USFDA’s tentative approval for Saxagliptin tablets

The US health regulator has provided its tentative approval to the drug firm Glenmark for its Saxagliptin tablets.

The company has said in a BSE filing that “Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration for Saxagliptin tablets, 2.5 mg and 5 mg, the generic version of Onglyza tablets, 2.5 mg and 5 mg of AstraZeneca AB.”

As per the IMS Health sales data for the 12 month period ending April 2017, the Onglyza tablets, 2.5 mg and 5 mg market achieved annual sales of approximately USD 518.5 million.

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