FDAsafety guidance72% confidence
FDA AP — POMALIDOMIDE (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Bristol Myers Squibb.
Regulatory Analysis
Application ANDA209956. Sponsor: TEVA PHARMS USA. Submission status: AP. Submission type: SUPPL. Active ingredients: POMALIDOMIDE.
Supporting Context
- Therapeutic area
- Oncology · Multiple Myeloma
- Sub-indication
- General
Related signal: Bristol-Myers Squibb Evaluates Pomalidomide Outcomes in Relapsed/Refractory Multiple Myeloma