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Aurobindo gets FDA nod for new drug
City-based Aurobindo Pharma on Thursday said it received final approval from the USFDA to manufacture and market pantoprazole sodium for injections, indicated for the treatment of gastroesophageal reflux disease, in the American market. The product is expected to be launched in the first quarter of next fiscal.
Hyderabad: City-based Aurobindo Pharma on Thursday said it received final approval from the USFDA to manufacture and market pantoprazole sodium for injections, indicated for the treatment of gastroesophageal reflux disease, in the American market. The product is expected to be launched in the first quarter of next fiscal.
"The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market pantoprazole sodium for injections, 40 mg/vial," Aurobindo Pharma said in a statement. The approved Abbreviated New Drug Applications (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product Protonix I.V. for injection, 40 mg/vial, of Wyeth Pharmaceuticals, it added.
Pantoprazole Sodium for Injection is a gastrointestinal drug used in the treatment of gastroesophageal reflux disease (GERD) associated with the history of erosive esophagitis. It is also indicated for the treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome in adults.
