Zenvision Pharma Gets CDSCO Panel Nod to Conduct BE Study on Rifaximin Sachets
New Delhi: The Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Zenvision Pharma LLP to conduct a bioequivalence (BE) study for its proposed Rifaximin sachets of 400 mg and 550 mg strength.
This came after the firm presented the proposal for a grant of permission to manufacture and market Rifaximin sachets of 400 mg and 550 mg along with Bioequivalence study protocol.
Rifaximin is a rifamycin-based non-systemic antibiotic used for the treatment of gastrointestinal bacterial infections, such as traveler's diarrhea and irritable bowel syndrome, and reduction of overt hepatic encephalopathy recurrence in adults.
Rifaximin acts by inhibiting RNA synthesis in susceptible bacteria by binding to the beta-subunit of the bacterial deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase enzyme. This binding blocks translocation, which stops transcription.
At the recent SEC meeting for gastroenterology and hepatology, the expert panel noted that Rifaximin tablets 400mg is approved on 18.07.2009 for the indication for the treatment of hepatic encephalopathy and Rifaximin tablets 550 mg were approved on 18.08.2011 for Reduction in Risk of Overt Hepatic Encephalopathy (HE) Recurrence in Patients of years of Age.
After detailed deliberation, the committee recommended the grant of permission to conduct a bioequivalence study as per the protocol presented by the firm.
Furthermore, the expert panel suggested that the firm should submit a BE report to CDSCO for further necessary action.
