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 10h 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 agent) for topical ocular use. It treats inflammatory conditions of the eye including conjunctivitis, uveitis, and corneal injury by suppressing inflammatory response and providing antimicrobial coverage. The corticosteroid inhibits edema, leukocyte migration, and fibroblast proliferation while the sulfacetamide provides bacteriostatic action against common ocular pathogens.
LOE Approaching
FML-S faces imminent loss of exclusivity with limited commercial investment, suggesting smaller team size and transition planning underway.
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.