Nexium approved for pediatric GERD
The FDA has approved Nexium Delayed-Release (esomeprazole magnesium, from AstraZeneca) 10mg oral suspension for the short-term treatment of gastroesophageal reflux disease (GERD) in patients 1-11 years of age. This approval is supported by the extrapolation of data from previous study results in adults to a pediatric population in addition to a trial involving 109 pediatric patients that demonstrated healing of their esophageal erosions after 8 weeks of treatment.
Nexium Delayed-Release 20mg and 40 mg oral suspension is already available for the short-term treatment of GERD in adolescent patients 12-17 years of age. In adults, Nexium is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. The 10mg dose is expected to be available later this year.
For more information call (800) 236-9933 or visit www.NEXIUM-US.com.