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
Launched in Thailand, the ASEAN hub, marking an early entry into the fast-growing combination therapy market (DPP-4 and SGLT-2 inhibitor combination) with strong potential for market leadership
The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets
Subscribe To Our Newsletter & Stay Updated