FDA gives tentative nod to Alembic’s generic Farxiga
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.
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.