NDAORALCONCENTRATE
Approved
Feb 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
GASTROCROM (cromolyn sodium) by Viatris is clinical pharmacology in vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. First approved in 1996.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GASTROCROM (cromolyn sodium) is an oral mast cell stabilizer that inhibits the release of histamine and leukotrienes from sensitized mast cells. It is used to treat mastocytosis and food allergy-induced gastrointestinal symptoms. The drug has minimal systemic absorption (<1% oral bioavailability) and acts locally in the gastrointestinal tract.
LOE Approaching
As LOE approaches, commercial teams are managing steady decline with limited brand investment; small, specialized field footprint likely remains.
Mechanism of Action
CLINICAL PHARMACOLOGY In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell. Cromolyn sodium has no intrinsic…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on GASTROCROM offers limited growth opportunity but provides stability in a specialized niche market managed by Viatris. Roles focus on regulatory compliance, legacy product management, and operational efficiency rather than brand-building or innovation.
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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.