FDAsafety guidance83% confidence
FDA AP — LENALIDOMIDE (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 ANDA209348. Sponsor: DR REDDYS. Submission status: AP. Submission type: SUPPL. Active ingredients: LENALIDOMIDE.
Supporting Context
- Therapeutic area
- Oncology · Multiple Myeloma
- Sub-indication
- General
Related signal: Bristol-Myers Squibb Compares Iberdomide to Lenalidomide in Multiple Myeloma Maintenance Therapy