FML-S
LOE ApproachingNDAOPHTHALMICSUSPENSION/DROPS
Approved
Sep 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
FML-S by AbbVie is clinical pharmacology corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Approved for inflammatory conditions of the palpebral, bulbar conjunctiva, cornea and 8 more indications. First approved in 1989.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FML-S is a fixed-dose ophthalmic suspension combining fluorometholone (a corticosteroid) and sulfacetamide sodium (an antimicrobial) for treating inflammatory eye conditions. It suppresses inflammatory response while providing antimicrobial coverage against susceptible bacteria, making it suitable for conditions where infection risk is a concern. The corticosteroid component inhibits edema, capillary dilation, leukocyte migration, and scar formation associated with ocular inflammation.
LOE Approaching
As an approaching LOE product, FML-S brand team faces revenue compression and likely smaller team resources focused on retention and cost management.
Mechanism of Action
CLINICAL PHARMACOLOGY Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and…
Indications (11)
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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.