NDAORALCONCENTRATE
Approved
Feb 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
GASTROCROM (cromolyn sodium) by Viatris (2) 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 10h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GASTROCROM (cromolyn sodium) is an oral mast cell stabilizer approved in 1996 for managing mastocytosis. It works by inhibiting the release of histamine and leukotrienes from sensitized mast cells, with no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity. The drug is poorly absorbed orally (≤1% bioavailability), with most of the dose excreted unchanged in feces.
LOE Approaching
Product approaching loss of exclusivity with limited current market traction; expect consolidation of team resources and focus on generic transition planning.
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 career growth given the approaching LOE and minimal linked job postings (0 identified). This assignment is best suited for professionals focused on generic transition strategy, rare disease expertise, or market-access complexity in niche therapeutics.
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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.