In addition, the expert panel suggested that the firm should explain the justification for the dose titration, international approval status, and the scientific literature available from a peer-reviewed journal in support of combining this FDC.
This came after the firm presented its proposal and requested for deliberation of BE & Phase III CT protocol for Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets.
At the recent SEC meeting for Endocrinology and Metabolism held on the 20th and 21st of April 2023, the expert panel reviewed the proposal presented by Synokem Pharmaceutical for deliberation of BE & Phase III CT protocol of the FDC Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets
After detailed deliberation, the committee recommended that the firm should justify on following points before presenting the protocol:
1. Firm should present the justification on rationality for combining this FDC and its significant benefit.
2. Justification on dose titration.
3. International approval status.
4. Scientific literature available from peer-reviewed journals in support of combining this FDC.
Accordingly, the expert panel suggested that the firm should submit the justification to CDSCO for review by SEC.
