Granules India Limited announced on Thursday that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg.
According to the company’s statement, it is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.
Esomeprazole Magnesium capsules are indicated for short-term treatment of heartburn and other symptoms associated GERD, risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for 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 US FDA (60 final and 2 tentative approvals).
The current annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 Million, according to MAT Jul 2023, IQVIA/IMS Health.
