FDAsafety guidance72% confidence
Compounding Safety Information: Quinacrine Hydrochloride
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Bayer.
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
- Cardiology · Coronary Artery Disease
- Sub-indication
- Hypertension
Related signal: Bayer's Study on Nitroglycerin and Nurandociguat Safety in CAD Patients