FDAsafety guidance66% confidence
Compounding Safety Information: Quinacrine Hydrochloride
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Novo Nordisk; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Quinacrine appears on the FDA 503B list of bulk drug substances that may be used in ccompounded drugs. FDA’s review for the 503B Bulks List determined that there is a clinical need for drug products compounded from quinacrine in the treatment of some patients with cutaneous lupus erythematosus.
Supporting Context
- Therapeutic area
- Endocrinology · GLP-1 Agonists
- Sub-indication
- General
Related signal: FDA Proposes Exclusion of Semaglutide, Tirzepatide, and Liraglutide from 503B Bulks List