Granules gets U.S. FDA nod for copy of AstraZeneca’s heartburn drug
The Hindu
Granules India receives US FDA approval for Esomeprazole Magnesium Delayed-Release Capsules, a generic version of AstraZeneca's Nexium. The annual US market for the drug is $168M, and Granules now has 62 ANDA approvals from the US FDA. Indicated for short-term treatment of GERD and reduction of NSAID-associated gastric ulcer, it can also be used for long-term treatment of pathological hypersecretory conditions.
Drugmaker Granules India has received U.S. Food and Drug Administration approval for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, a generic version of AstraZeneca Pharmaceuticals Nexium Delayed-Release Capsules.
Bioequivalent and therapeutically equivalent to reference listed drug 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 with gastroesophageal reflux disease (GERD).
The current annual U.S. market for Esomeprazole Magnesium Delayed-Release Capsules is around $168 Million, Granules said, citing MAT Jul 2023 IQVIA/IMS Health numbers, in a release on U.S. FDA approving its abbreviated new drug application (ANDA). The company said it now has 62 ANDA approvals from the U.S. FDA (60 final and 2 tentative approvals).
Esomeprazole Magnesium capsules are also indicated for reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults as well as for long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
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