Granules India Limited announced on Wednesday that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg and 40 mg.
According to a press statement, it is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Protonix Delayed-Release Tablets, 20 mg and 40 mg, of Wyeth Pharmaceuticals LLC.
Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD), Maintenance of Healing of Erosive Esophagitis and Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome.
Granules now have a total of 64 ANDA approvals from the US FDA (62 final approvals and 2 tentative approvals).
The current annual U.S. market for Pantoprazole Tablets is approximately $233 million, according to IQVIA/IMS Health, MAT Oct 2023.