Generic Esomeprazole Approved

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The US Food and Drug Administration approved the first generic version of AstraZeneca's heartburn blockbuster, Nexium.

The US Food and Drug Administration (FDA) approved esomeprozole magesium delayed release capsules, Ivax Pharmaceuticals' generic version of AstraZeneca's Nexium.

The drug is meant for adults and children over age 1. Ivax plans to sell the drug in 20 mg and 40 mg capsules.

Esomeprozole is prescribed for gastroesophageal reflux, gastric ulcers, and other conditions in which there is a benefit to reducing stomach acid.

Adverse events reported in trials included headache, diarrhea, nausea and other minor problems. The most serious potential side effect is increased risk of bone fractures when the drug is taken for extended periods.

Nexium has been a blockbuster for AstraZenaca with annual global sales of $3.9 billion, most of that in the US. It went off patent in May 2014.

Ivax is the first generic version to get FDA approval.

Ranbaxy Labs in Gurgaon, India submitted a generic candidate to the FDA but the agency rejected its application due to manufacturing deficiencies at 2 pharma plants in India that Ranbaxy had used.

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