Alembic Pharmaceuticals Limited has announced the receipt of Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial). This approval positions Alembic’s product as a therapeutically equivalent alternative to Protonix I.V. for Injection, 40 mg/vial, from Wyeth Pharmaceuticals LLC.
Pantoprazole Sodium for Injection is indicated for the treatment of gastroesophageal reflux disease (GERD) and erosive esophagitis (EE) for up to 10 days in adults. Additionally, it is used to treat pathological hypersecretion conditions, including Zollinger-Ellison (ZE) Syndrome.
The product is projected to tap into a significant market, with an estimated market size of $48 million for the twelve months ending December 2024, according to IQVIA.
This approval adds to Alembic’s growing portfolio of USFDA-approved products, bringing its cumulative total to 221 ANDA approvals, including 195 final and 26 tentative approvals.
With this milestone, Alembic Pharmaceuticals continues to strengthen its position in the US market, offering high-quality generic alternatives to branded drugs.