FDAsafety guidance66% confidence
FDA TA — CANAGLIFLOZIN (ORIG)
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Cipla; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA210451. Sponsor: TEVA PHARMS USA. Submission status: TA. Submission type: ORIG. Review priority: STANDARD. Active ingredients: CANAGLIFLOZIN.
Supporting Context
- Therapeutic area
- Hematology · Multiple Myeloma
- Sub-indication
- General
Related signal: Cipla's Lenalidomide ANDA213165 Receives AP Status from FDA