Granules India has received approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, of AstraZeneca Pharmaceuticals LP.
Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms, risk reduction of nonsteroidal anti-inflammatory drugs-associated gastric ulcer in adults at risk of developing gastric ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin, and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Granules now have a total of 62 ANDA approvals from the USFDA (60 final and 2 tentative approvals).
The current annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 million, according to a release.