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FDA gives Ranbaxy approval for first generic Nexium

2/15/2008

WASHINGTON The Food and Drug Administration approved the generic version of the drug Nexium (esomeprazole magnesium), which marks the first approval for any generic version of the drug.

Nexium, produced by AstraZeneca, is indicated for treatment in short-term esophagitis, and also for heartburn and other symptoms that result from gastroesophageal reflux disease.

Ranbaxy claims to have made the first application, which includes 20 mg and 40 mg capsules, and the approval has provided the company with an extra 180 days exclusivity to market the drug.

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