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.
UNI AR GR SM1315
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.
UNI AR GR SM1315
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