FDA gives tentative nod to Alembic’s generic Farxiga

Press enter to search
Close search
Open Menu

FDA gives tentative nod to Alembic’s generic Farxiga

By Sandra Levy - 07/25/2019
The Food and Drug Administration has given tentative approval to Alembic for dapagliflozin tablets, in dosage strengths of 5 mg and 10 mg.

The product is the generic of AstraZeneca’s Farxiga tablets.

It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dapagliflozin tablets had a market value of about $ 1.7 billion for the 12 months ending December 2018, according to IQVIA.

RELATED TOPICS