On February 14, Puli Pharmaceuticals announced that it had recently received a marketing approval notice for generic esomeprazole sodium for injection issued by the US FDA
.
Indications are: 1.
As an alternative therapy for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis (EE) in adults and children aged 1 month to 17 years when oral therapy is not appropriate
.
2.
Reduce the risk of rebleeding after therapeutic endoscopy for acute bleeding of gastric or duodenal ulcers in adults
.
Esomeprazole, also known as esomeprazole, is a single levorotatory isomer of omeprazole, both of which are proton pump inhibitors, which can effectively inhibit gastric acid secretion and are clinically used for the treatment of gastroesophageal reflux disease.
Fluid disease, erosive reflux esophagitis,
etc.
The drug is one of the most successful examples of isomer development, with stronger gastric acid inhibition and fewer adverse reactions than the first-generation omeprazole
.
It was first developed by AstraZeneca, and its oral preparation was launched in Sweden in 2000 under the trade name of Nexium.
Its injection was launched in 2003 and was approved by the US Food and Drug Administration (FDA) in March 2005
.