AstraZeneca has received US Food and Drug Administration (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.
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.
Nexium is the first proton pump inhibitor approved for use in infants younger than one year old.
AstraZeneca executive director of gastrointestinal disorders Marta Illueca said that the approval of Nexium gives physicians an option to treat infants and children.
The injection should be used only when oral therapy with Nexium is not possible or appropriate.
The adverse affects reported with Nexium IV include headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhoea, dry mouth, dizziness or vertigo, constipation and itching.