FDA approves first generic version of Nexium

FDA approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules, Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.

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The generic Nexium will be marketed in 20-mg and 40-mg capsules.

“The introduction of a generic version of the popular ulcer/GERD medication, Nexium, marks yet another milestone in the latest string of blockbuster, non-specialty drug products which have reached patent expiration in recent years,” said FormularyWatch Advisor David Calabrese, vice president and chief pharmacy officer, Catamaran. 

“As one of the most frequently prescribed brand name medications in the United States today, the availability of a generic alternative to Nexium in Ivax’s esomeprazole, represents welcomed relief for payers and for patients alike amidst a time of increasing financial pressures,” Calabrese said.  

Esomeprazole capsules are also approved to reduce the risk of gastric ulcers associated with use of NSAIDs, treat the stomach infection Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.

Gastroesophageal reflux (GER) happens when stomach contents come back up into the esophagus. Stomach acid that touches the lining of the esophagus can cause acid indigestion (also called acid reflux or heartburn). GERD is a more serious, chronic form of GER. GER that occurs more than twice a week for a few weeks could be GERD, which over time can lead to more serious health problems, such as esophagitis and respiratory problems.

PPIs may disrupt healthy gut microbiome, raise infection risk

Generic esomeprazole capsules will be dispensed with a patient Medication Guide that provides important information about the medication’s use and risks. The most serious risks are stomach problems, including severe diarrhea, and a warning that people who take multiple daily doses of PPIs for a long period of time may have an increased risk of bone fractures. 

In clinical trials, the most common side effects of Nexium that were reported include headache, diarrhea, nausea, flatulence, abdominal pain, sleepiness, constipation, and dry mouth.