Alembic Pharmaceuticals secures US FDA approval for Pantoprazole Sodium Injection
Regulatory clearance enables Alembic to launch generic equivalent of Protonix I.V. in the US market
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). The approved product is therapeutically equivalent to Protonix I.V. for Injection, 40 mg/vial, developed by 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 Syndrome in adults.
According to IQVIA, the estimated market size for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial), for the twelve months ending December 2024 is approximately $48 million.
Alembic Pharmaceuticals now holds a total of 221 ANDA approvals from the USFDA, comprising 195 final approvals and 26 tentative approvals.