Mumbai, April 1 -- The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Protonix I.V. for Injection, of Wyeth Pharmaceuticals LLC. Pantoprazole sodium for injection is indicated for the 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. Refer to the label for a detailed indication.

According to IQVIA, the estimated market size for pantoprazole sodium for injection was US$ 48 million for the twelve months ending December 2024.

With this approval, Alembic has a cumulative total of 221 ANDA approva...