Cipla Gets USFDA Approval For Esomeprazole

Drug major Cipla on Thursday said it has received final approval from the US health regulator for generic Esomeprazole for oral suspension used for treatment of gastroesophageal reflux disease. The company has received final approval for its abbreviated new drug application (ANDA) for Esomeprazole for oral suspension in the strengths of 10mg, 20mg and 40mg from the United States Food and Drug Administration (USFDA), Cipla said in a statement. Cipla is the first company to file for the 10mg strength, it added. The product is a generic version of AstraZeneca Pharmaceutical’s Nexium. It is indicated for the treatment of gastroesophageal reflux disease, risk reduction of NSAID-associated gastric ulcer, among others, Cipla said. According to IQVIA, Nexium and its generic equivalents had US sales of around USD 70 million for the 12 months ended November 2019, it added.

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