SANDIMMUNE
LOE ApproachingNDAORALSOLUTIONPriority Review
Approved
Nov 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
SANDIMMUNE by Novartis is clinical pharmacology mechanism of action cyclosporine is a potent immunosuppressive agent, which in animals prolongs survival of allogeneic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine, and lung. First approved in 1983.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SANDIMMUNE (cyclosporine) is a potent small-molecule immunosuppressant that selectively inhibits T-lymphocyte activation and lymphokine production. It is indicated for organ transplant rejection prophylaxis (kidney, liver, heart) and acts by blocking cell-mediated immunity without suppressing bone marrow or phagocytic function. The drug has been a cornerstone of transplant immunology since FDA approval in 1983.
LOE Approaching
As LOE approaches, the brand team is likely focused on managed decline, switching strategies to newer agents, and defending core transplant segments against competitive erosion.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Cyclosporine is a potent immunosuppressive agent, which in animals prolongs survival of allogeneic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.