AstraZeneca seeks approval for use of Nexium in infants
NEW YORK AstraZeneca has submitted a supplemental application to the Food and Drug Administration for the use of the drug Nexium as a short-term treatment of gastroesophageal reflux disease in infants.
GERD, which is closely related to acid-reflux disease, affects about 7 million children in the United States.
The FDA has already approved Nexium (esomeprazole magnesium) for use in children between 1 and 17 years of age, though AstraZeneca hopes to have it approved in infants less than a year old.