FDA Approves Generic Form of Nexium

Share this content:
FDA Approves Generic Form of Nexium
FDA Approves Generic Form of Nexium

TUESDAY, Jan. 27, 2015 (HealthDay News) -- The first generic version of Nexium (esomeprazole magnesium delayed-release capsules) has been approved by the U.S. Food and Drug Administration to treat gastroesophageal reflux disease in adults and children ages 1 and older.

Esomeprazole also is approved to reduce the likelihood of gastric ulcers associated with nonsteroidal anti-inflammatory drugs, the agency said. It is also approved to treat Helicobacter pylori along with certain antibiotics, and to treat conditions where the stomach makes too much acid, including Zollinger-Ellison syndrome.

A medication guide distributed with the drug warns of potential problems, including severe diarrhea and, with extended use, the greater potential for bone fractures, the FDA said. The most common side effects of esomeprazole include headache, diarrhea, nausea, flatulence, abdominal pain, fatigue, constipation, and dry mouth.

The FDA stressed that approved generic drugs are of the same strength and quality as their brand-name equivalents. License to produce generic esomeprazole in 20 and 40 mg capsules was granted to Ivax Pharmaceuticals, a subsidiary of the Israeli firm Teva Pharmaceuticals.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Drug Lookup

Browse drugs by: BrandGenericDisease

Trending Activities

All Professions



Sign up for myCME e-newsletters




More in Home

FDA Approves Palynziq for Phenylketonuria

FDA Approves Palynziq for Phenylketonuria

Drug is a novel enzyme therapy for adult patients with PKU with uncontrolled blood Phe concentrations

Increase in Tx Candidates With 2017 Hypertension Guidelines

Increase in Tx Candidates With 2017 Hypertension Guidelines

Increase in proportion of adults recommended for treatment; estimated decrease in CVD events, deaths