Alembic Pharmaceuticals receives USFDA approval for Pantoprazole sodium for injection
India, April 2 -- Alembic Pharmaceuticals has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDAPantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, 40 mg/vial, of Wyeth Pharmaceuticals LLC.Pantoprazole sodium for injection is indicated for treatment of gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE) for up to 10 days in adults. It is also indicated for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults. Pantoprazole Sodium for Injection, 40 mg/vial (Sing...
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