The U.S. Food and Drug Administration today approved the first
generic version of Nexium (esomeprazole magnesium delayed-release
capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.
Ivax
Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA, has
gained approval to market esomeprazole in 20 and 40 milligram capsules.
“Health
care professionals and consumers can be assured that these FDA-approved
generic drugs have met our rigorous standards,” said Kathleen Uhl,
M.D., director of the Office of Generic Drugs in the FDA’s Center for
Drug Evaluation and Research. “It is important for patients to have
access to treatment options for chronic conditions.”
Esomeprazole
capsules are also approved to reduce the risk of gastric ulcers
associated with use of nonsteroidal anti-inflammatory drugs (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, long-lasting (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 inflammation of the
esophagus (esophagitis) and respiratory problems.
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.
The most common side effects reported by those taking
Nexium in clinical trials include headache, diarrhea, nausea,
flatulence, abdominal pain, sleepiness, constipation, and dry mouth.
Generic
prescription drugs approved by the FDA have the same high quality and
strength as brand-name drugs. Generic prescription drug manufacturing
and packaging sites must pass the same quality standards as those of
brand-name drugs.
The FDA, an agency within the U.S. Department of
Health and Human Services, protects the public health by assuring the
safety, effectiveness, and security of human and veterinary drugs,
vaccines and other biological products for human use, and medical
devices. The agency also is responsible for the safety and security of
our nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco products.