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Last Updated : Mar 26, 2020 01:39 PM IST | Source: PTI

Cipla gets USFDA nod for generic acid reflux drug

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.

 
 
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Drug major Cipla on March 26 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.

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According to IQVIA, Nexium and its generic equivalents had US sales of around $70 million for the 12 months ended November 2019, it added.

Shares of Cipla were trading at Rs 389 per scrip on the BSE, up 3.27 percent from the previous close.

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First Published on Mar 26, 2020 01:15 pm
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