AstraZeneca GERD Drug Approved by FDA

The FDA has approved esomeprazole sodium for injection as a new short-term treatment option for children suffering from gastroesophageal reflux disease with erosive esophagitis.

British drugmaker AstraZeneca said Monday it had received US FDA approval for Nexium IV (esomeprazole sodium) injection for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis in children older than one month. Nexium is the first proton pump inhibitor approved for use in infants younger than one year old.

Erosive esophagitis, associated with GERD, leads to inflammation of the oesophagus because of acidic reflux. Symptoms of GERD include irritability, vomiting, difficulty in swallowing, weight loss, regurgitation and heartburn.

AstraZeneca executive director of gastrointestinal disorders Marta Illueca said that the approval of Nexium gives physicians an option to treat infants and child