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
Decision on EU marketing authorisation expected for momelotinib by early 2024
Evinova will operate as a separate health-tech business within AstraZeneca
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.
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
Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain
Collaboration enables Brenntag to serve pharma customers in EMEA with chromatography silica gels
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