Granules India gets USFDA nod for generic drug used to treat heartburn

Granules India Ltd on Thursday said it has received approval from the US health regulator for its generic Esomeprazole Magnesium delayed-release capsules indicated for short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.

The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Esomeprazole Magnesium delayed-release capsules of strengths 20 mg and 40 mg, Granules India said in a regulatory filing.

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 and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome, it added.

The current annual US market for Esomeprazole Magnesium delayed-release capsules is approximately USD 168 million, the company said citing IQVIA/IMS Health July 2023 data.