Cipla announces final approval for generic Nexium in 10mg, 20mg and 40mg; First to file for the 10mg strength
30 March 2020 -

Pharmaceutical company Cipla Limited (BSE:500087) (NSE:CIPLA EQ) disclosed on Friday the receipt of US Food and Drug Administration final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension in 10mg, 20mg and 40mg .

The company stated that it is the first to file for Esomeprazole for Oral Suspension the 10mg strength.

Cipla added that the Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical's Nexium. The product is available for shipping immediately.

Nexium is a proton pump inhibitor indicated for treatment of gastroesophageal reflux disease (GERD), risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence as well as pathological hypersecretory conditions, including Zollinger-Ellison syndrome, revealed the company.

According to IQVIA (IMS Health), Nexium and its generic equivalents had US sales of approximately USD70m for the 12-month period ending November 2019.