Mumbai, Feb 7 (UNI) Ranbaxy Laboratories 2008 has received tentative approval from the US Food and Drug Administration to manufacture and market Esomeprazole Magnesium Delayed-Release capsules in USA.
Esomeprazole is the second largest selling drug in USA with total annual market sales of USD 5.5 billion.
Ranbaxy believes that it has a first to file status on the drug, providing it with a potential 180 days marketing exclusivity, thereby offering a significant opportunity in the future, a release said.
Esomeprazole is indicated for the short-term treatment (four to eight weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis and for treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.
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