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Aurobindo gets FDA nod for new drug
Drug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market Esomeprazole Magnesium delayed release capsules, used in treatment of gastroesophageal reflux disease, in the American market.
Hyderabad: Drug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market Esomeprazole Magnesium delayed release capsules, used in treatment of gastroesophageal reflux disease, in the American market.
The company said the launch of the product is based on the settlement terms/litigation outcome with AstraZeneca. "The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Esomeprazole Magnesium delayed release capsules USP, 20mg and 40 mg," Aurobindo Pharma said in a BSE filing.
The approved abbreviated new drug application (ANDA) is bio equivalent and therapeutically equivalent to the reference listed drug product Nexium delayed release capsules USP, 20mg and 40 mg, of AstraZeneca Pharmaceuticals, it added.
