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Home Industry News AstraZeneca submits new drug application

AstraZeneca submits new drug application

22nd December 2008

AstraZeneca has said it has submitted a supplemental new drug application.

The company’s request for Nexium (esomeprazole magnesium) is to seek approval for the short term treatment of gastroesophageal reflux disease (GERD) in patients aged nought to one year old.

Currently affecting seven million children in the US, the condition sees sufferers’ stomachs rejecting contents back up in to the oesophagus, causing pain, constant or sudden crying, frequent vomiting and irritability.

Marta Illueca, Nexium brand medical director at AstraZeneca, said: “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.”

She added close medical supervision is “key” in appropriate diagnosis and choice of treatment.

The filing for approval also included 2.5 mg and five mg strengths of Nexium for delayed-release oral suspension.

Mixed with water, the granular formulation is administered orally or via feeding tubes and is currently available in ten mg, 20 mg and 40 mg prescriptions.

Last week, AstraZeneca said it had awarded Infosys a five-year global sourcing contract.

Under the agreement, AstraZeneca will receive end-to-end application maintenance services, including manufacturing, supply chain, human resources and finance.

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