Ahmedabad, Feb. 4 -- Ahmedabad:Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga(R)Tablets, 5 mg and 10mg).
Dapagliflozinisasodium-glucosecotransporter2(SGLT2)inhibitorindicatedasanadjuncttodietand exercise to improve glycaemic control in adults with type 2 diabetes mellitus.
Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ,Ahmedabad.
DapagliflozintabletshadannualsalesofUSD10,486.9mnintheUnitedStates(IQVIAMATDecember 2025).
The group now has 430 approvals and has so far filed 505* ANDAs s...