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Granules India receives USFDA approval for its acid reflux treatment tablets
The tablets are used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease, and healing of pathological hypersecretory conditions including Zollinger Ellison (ZE) syndrome.
- By PharmaNews Live Desk
- New Delhi
- Dec 13, 2023
Granules India Limited on 13 December announced that it has received approval of the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-Release Tablets, in the dosages of 20mg and 40mg.
The tablets are used in the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease, and healing of pathological hypersecretory conditions including Zollinger Ellison (ZE) syndrome.
According to the press statement, the approved ANDA is bioequivalent as well as therapeutically equivalent to the reference-listed drug (RLD) Protonix Delayed-Release Tablets, of Wyeth Pharmaceuticals LLC’s, having the same dosages of 20 mg and 40 mg.
Pantoprazole Sodium Delayed-Release Tablets are indicated for the short-term treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD),
The pharmaceutical company now has a total of 64 ANDA approvals from the US FDA (62 final approvals and 2 tentative approvals).
According to IQVIA/IMS Health, MAT Oct 2023, the current annual US market for Pantoprazole Tablets is approximately $233 million.