Dr Reddy's Gets CDSCO Panel Nod To Import, Market Saccharomyces Boulardii, BE, CT Waived
New Delhi: Granting the bioequivalence study waiver and clinical trial study waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved Dr Reddy's Laboratories proposal to import and market of Saccharomyces Boulardii CNCM I-745, 250 mg/ 8 ml powder and solvent for oral suspension.
This came firm presented the proposal for import and market of Saccharomyces Boulardii CNCM I-745, 250 mg/ 8 ml powder and solvent for oral suspension for the
-Treatment of acute infectious diarrhoea in adults and children.
- Prevention and treatment of antibiotic associated colitis and diarrhoea.
- In addition to vancomycin/ metronidazole treatment to prevent recurrence of Clostridium difficile disease (CDD).
- Supportive in the treatment of diarrhea occurring in irritable bowel syndrome (IBS).
Along with justification for BE waiver and CT waiver before the committee.
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