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.