Granules India gets USFDA nod for generic pantoprazole sodium tablets

The approval by the US Food and Drug Administration (USFDA) is for an abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets in 20mg and 40mg strengths, Granules India said in a regulatory filing.

Granules India Ltd. on Wednesday announced that it has received approval from US health regulators for generic pantoprazole sodium delayed-release tablets used for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease.

The approval by the US Food and Drug Administration (USFDA) is for an abbreviated new drug application (ANDA) for pantoprazole sodium delayed-release tablets in 20mg and 40mg strengths, Granules India said in a regulatory filing.

It added that it is bioequivalent and therapeutically equivalent to reference-listed Wyeth Pharmaceuticals' Protonix delayed-release tablets (20 mg and 40 mg concentrations).

Pantoprazole sodium extended-release tablets are indicated for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD). GERD is a condition in which acid reflux from the stomach can cause heartburn and damage to the esophagus.

It added that the drug is also used to maintain healing in pathological hypersecretory conditions such as erosive esophagitis and Zollinger-Ellison (ZE) syndrome.

The company said the current annual U.S. market for pantoprazole tablets is approximately $233 million, citing October 2023 data from IQVIA/IMS Health, MAT.