Granules India receives USFDA approval for generic heartburn medication

Granules India Ltd has gained approval from the US Food & Drug Administration (USFDA) for its generic Esomeprazole Magnesium delayed-release capsules. These capsules are designed for the short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.

The approval covers strengths of 20 mg and 40 mg. Granules India affirmed that its product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20 mg and 40 mg, marketed by AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium capsules are used for the short-term treatment of heartburn and related symptoms of GERD. They also serve in the risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcers in adults and for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

According to IQVIA/IMS Health July 2023 data, the current annual market for Esomeprazole Magnesium delayed-release capsules in the US is approximately USD 168 million. This regulatory approval marks a significant advancement for Granules India in expanding its portfolio of generic medications.