The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
Results from the DELIVER and DAPA-HF Phase III trials demonstrate Dapagliflozin’ efficacy in heart failure regardless of ejection fraction
The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad
The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Here's a development that aims to keep your blood pressure in check. Literally!
The platform is being introduced to expand access to treatments for people living with chronic conditions
During this quarter, the company achieved a key milestone of reaching 1,000 DCGI approvals
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