BDR Pharmaceutical Gets CDSCO Panel Nod for Bioequivalence Study of Elobixibat tablet
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug maker BDR Pharmaceutical to conduct a bio-equivalence study of Elobixibat Tablets 5 mg.
Furthermore, the expert panel stated that the result of the bio-equivalence study should be presented before the committee for further consideration.
This came after BDR Pharmaceutical presented the proposal for grant of permission to manufacture and market Elobixibat Tablets 5 mg along with the bioequivalence study protocol before the committee.
Elobixibat is a drug used to treat chronic constipation and irritable bowel syndrome with constipation. It works by increasing the amount of bile acid in the colon after eating, which stimulates bowel function. Elobixibat is an inhibitor of the ileal bile acid transporter (IBAT), which interrupts the enterohepatic circulation of bile acids. This increases the amount of bile acid in the gut.
At the recent SEC meeting for gastroenterology and hepatology held on 12th December 2024, the expert panel reviewed the proposal for grant of permission to manufacture and market Elobixibat Tablets 5 mg along with the bioequivalence study protocol.
After detailed deliberation, the committee noted that drug Elobixibat Tablets 5 mg were already approved in the country to manufacture and market for sale.
Accordingly, the committee recommended the grant of permission to conduct a bio-equivalence study as per the protocol presented. Furthermore, the expert panel stated that the result of the bio-equivalence study should be presented before the committee for further consideration.
