Aurobindo Pharma receives USFDA Approval for Pantoprazole Sodium for Injection

31 Mar 2016 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Pantoprazole Sodium for Injection, 40 mg/vial (single-dose vial). This product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Protonix I.V. for Injection, 40 mg/vial, of Wyeth Pharmaceuticals, Inc.

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. The approved product has an estimated market size of $ 93.5 million for the twelve months ending February 2016 according to IMS.

This is the 29th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 249 ANDA approvals (213 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.

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