Dapagliflozin biosimilar gets tentative FDA approval

The marketing application for a generic version of Farxiga, or dapagliflozin has received tentative approval from the US Food and Drug Administration (USFDA). Alembic Pharmaceuticals received a nod for its abbreviated new drug application for Dapagliflozin Tablets in 5 mg and 10 mg strength.

The approved product is therapeutically equivalent to the reference listed drug product Farxiga Tablets.

No information on pricing has been posted yet, but the hope is that as patents expire, more affordable generic diabetes medications will be made available.

Dapagliflozin belongs to the SGLT-2 Inhibitor class of diabetes medications. To read more, download our FREE Diabetes Medication Pocket Cards.

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