Granules India Receives USFDA Approval for Generic Esomeprazole Magnesium Capsules

19 Oct 2023 , 03:11 PM

Granules India Ltd has received approval from the US Food & Drug Administration (USFDA) for its generic Esomeprazole Magnesium delayed-release capsules. The approved capsules come in strengths of 20 mg and 40 mg and are indicated for the short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD).

These capsules are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, produced by AstraZeneca Pharmaceuticals LP.

In addition to heartburn, Esomeprazole Magnesium capsules are also prescribed for risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

The annual US market for Esomeprazole Magnesium delayed-release capsules is estimated to be around USD 168 million, as per IQVIA/IMS Health data from July 2023.

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