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Alembic Pharma gets FDA nod for glycemic drug
Highlights
Drug firm Alembic Pharmaceuticals on Tuesday said it has received tentative approval from the US health regulator for Dapagliflozin Tablets, a medication that helps to reduce blood glucose levels.
New Delhi: Drug firm Alembic Pharmaceuticals on Tuesday said it has received tentative approval from the US health regulator for Dapagliflozin Tablets, a medication that helps to reduce blood glucose levels.
The approved product is therapeutically equivalent to the reference listed drug product Farxiga Tablets of AstraZeneca AB.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Dapagliflozin Tablets in the strengths of 5 mg and 10 mg, Alembic Pharmaceuticals said in a BSE filing.
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