Cipla gets FDA green light for generic Nexium

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Cipla gets FDA green light for generic Nexium

By Sandra Levy - 03/27/2020

Patients with gastroesophageal reflux disease have a new generic treatment available.

Cipla has received the Food and Drug Administration’s blessing for esomeprazole for oral suspension in dosage strengths of 10 mg, 20 mg and 40 mg. Cipla is the first company to file for the 10 mg strength.

Cipla's product is the generic of AstraZeneca’s Nexium.

It is a proton pump inhibitor indicated for the following: treatment of gastroesophageal reflux disease; the risk reduction of NSAID-associated gastric ulcer; H. pylori eradication to reduce the risk of duodenal ulcer recurrence; and pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Cipla's generic Nexium is immediately available for shipping.

Nexium and its generic versions had a market of approximately $70 million for the 12 months ended November 2019, according to IQVIA.

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