Nexium I.V. is a proton pump inhibitor indicated for the treatment of GERD with erosive esophagitis in adults and pediatric patients greater than one month of age, when oral therapy is not possible or appropriate.
AstraZeneca Gastrointestinal Disorders executive director Marta Illueca said this approval represents an important contribution to an unmet medical need for infants in particular.
"While some reflux and regurgitation are normal in infants and may not require medical treatment, persistent GERD symptoms can be very uncomfortable and cause damage to the esophagus, just as they can in older patients," Illueca said.