NDAOPHTHALMICEMULSIONPriority Review
Approved
Dec 2002
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
RESTASIS MULTIDOSE (cyclosporine) by AbbVie is calcineurin inhibitors [moa]. Approved for kidney transplantation, heart transplantation, graft vs host disease and 2 more indications. First approved in 2002.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RESTASIS MULTIDOSE is a calcineurin inhibitor immunosuppressant ophthalmic emulsion containing cyclosporine, approved by the FDA on December 23, 2002. It is indicated for the treatment of keratoconjunctivitis sicca (dry eye disease) by reducing ocular inflammation and promoting tear production. The drug works by inhibiting calcineurin, thereby suppressing T-cell activation and reducing inflammatory cytokines at the ocular surface. RESTASIS MULTIDOSE represents a convenient multidose formulation of the established cyclosporine therapy, positioning it as a maintenance treatment option in the dry eye management landscape.
$0.1BPart D
8.0 years to LOEMechanism of Action
Calcineurin Inhibitors
Pharmacologic Class:
Calcineurin Inhibitor Immunosuppressant
Indications (5)
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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.