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 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GASTROCROM (cromolyn sodium) is an oral concentrate mast cell stabilizer approved in 1996 that inhibits the release of histamine and leukotrienes from sensitized mast cells. It is indicated for gastrointestinal mast cell-mediated conditions and works through a unique mechanism of action with no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity. The drug has minimal systemic absorption, with less than 1% oral bioavailability, making it a localized GI therapeutic.
LOE Approaching
Approaching loss of exclusivity with minimal current branded team investment; roles focused on transition planning and generic preparation rather than market expansion.
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 in a LOE-approaching lifecycle offers limited growth prospects and primarily defensive career positioning. Roles focus on market management during transition to generic competition and extraction of remaining revenue rather than innovation or expansion.
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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.