Alembic Pharmaceuticals announced that the Company has received tentative
approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug
Application (ANDA) Dapagliflozin Tablets, 5 mg and 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB (AstraZeneca).
Dapagliflozin 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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