Drug Approval | November 22, 2023
Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
Azelis will be the exclusive distributor for inulin, oligofructose, scFOS, texturized wheat proteins, faba beans, Beta-glucans, meatless solution
Evinova will operate as a separate health-tech business within AstraZeneca
OCEANIC-AF is one trial which evaluates asundexian versus apixaban in patients with atrial fibrillation at risk for stroke within the overall OCEANIC phase III program
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
Emphasizes the need for a collective effort on bolstering resilience across economies, societies, healthcare systems, education systems and infrastructure
Gene therapy AB-1005 being developed to locally increase glial cell line-derived neurotrophic factor (GDNF) levels
The product will be manufactured at Lupin’s Nagpur facility in India
This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering
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