FDAsafety guidance72% confidence
FDA AP — REVLIMID (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 NDA021880. Sponsor: BRISTOL MYERS SQUIBB. Submission status: AP. Submission type: SUPPL. Review priority: N/A. Active ingredients: LENALIDOMIDE.
Supporting Context
- Therapeutic area
- Neurology · Bipolar Disorder
- Sub-indication
- General
Related signal: Bristol-Myers Squibb Evaluates KarXT for Bipolar-I Disorder Manic Episodes