Lupin gets USFDA nod to market generic diabetes drug
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Dapagliflozin and Saxagliptin tablets, the Mumbai-based drug maker said in a regulatory filing.
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Drug firm Lupin on Thursday said it has received approval from the US health regulator to market a generic medication to treat diabetes.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Dapagliflozin and Saxagliptin tablets, the Mumbai-based drug maker said in a regulatory filing.
The company's product is a generic equivalent of AstraZeneca AB's Qtern tablets, it added. This generic product will be manufactured at its Pithampur facility, the company said.
Dapagliflozin and Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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