CDSCO panel gives nod for Esomeprazole Dual Release Gastro resistant Tablets

This leads to the inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus.

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CDSCO Panel
CDSCO Panel

Last Updated on December 6, 2022 by The Health Master

New Delhi: Pharmaceutical major Sun Pharma has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Organization (CDSCO) to manufacture and market Esomeprazole dual release gastro-resistant tablets 80 mg indicated for the treatment of moderate to severe refractory gastro-oesophageal reflux disease (GERD) for 4 weeks only.

This came after the drug company Sun Pharma presented the proposal for manufacturing and marketing Esomeprazole dual-release gastro-resistant tablets 80 mg along with the results of the Phase III clinical trial.

Earlier, the Medical Dialogues Team had reported that the Subject Expert Committee (SEC) had told Sun Pharma to conduct a Phase III Clinical Trial with Esomeprazole dual-release gastro-resistant tablets 80 mg vs. Esomeprazole gastro-resistant tablets 40 mg for the proposed indication.

Esomeprazole is a proton pump inhibitor that is used to treat gastroesophageal reflux disease (GERD), reduce the risk of nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcers, eradicate H. pylori, and treat conditions causing gastric acid hypersecretion.

Esomeprazole suppresses stomach acid by covalently binding to the sulfhydryl groups of cysteines found on the H+, K+)-ATPase enzyme on the secretory surface of gastric parietal cells, which prevents the final step in gastric acid production.

This leads to the inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus.

Sun Pharma marketed esomeprazole 40 mg under the brand names Sompraz 40 mg Tab, Raciper-40mg Tab. Apart from this, some popular brands of esomeprazole 40 mg include Glenmark’s Esoz Fast 40 mg Tablet, Cipla’s Esomac 40 mg Injection, Torrent Pharma’s Nexpro 40mg Injection, Cadila Pharma’s Espra-40mg Tab, etc.

Now, in continuation, at the recent SEC meeting for gastroenterology and hepatology, dated November 23, 2022, the committee thoroughly examined the proposal for the manufacturing and marketing of Esomeprazole dual-release gastro-resistant tablets 80 mg, along with the results of Phase III clinical trial.

After detailed deliberation, the committee recommended the manufacturing and marketing of Esomeprazole dual-release gastro-resistant tablets 80 mg, “indicated for the treatment of moderate to severe refractory gastro-oesophageal reflux disease (GERD) for 4 weeks only.”

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