Lupin receives tentative approval from USFDA for Dapagliflozin and Saxagliptin tablets
Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
Dapagliflozin and Saxagliptin Tablets (RLD Qtern) had estimated annual sales of US $5 million in the US
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Glenmark's Zita portfolio of medicines have been benefiting around 1.75 million Type 2 diabetic patients annually
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
Funding round led by Sarissa Capital, includes Sun Pharma, Polaris Partners
The product basket increased to 1800 medicines and 285 Surgical Equipment
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