SEREVENT
LOE ApproachingNDAINHALATIONAEROSOL, METEREDPriority Review
Approved
Feb 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
4/8 — Partial
Priority Review
SEREVENT by GSK is laba. Approved for asthma, the prevention of bronchospasm only, older with reversible obstructive airway disease and 3 more indications. First approved in 1994.
Drug data last refreshed 3d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEREVENT (salmeterol) is a long-acting beta-2 agonist (LABA) inhaled as a metered aerosol for chronic obstructive pulmonary disease. It works by stimulating beta-2 adrenergic receptors in bronchial smooth muscle, increasing cyclic AMP and causing bronchodilation while inhibiting mast cell mediator release. Salmeterol is at least 50 times more selective for beta-2 adrenergic receptors than albuterol, providing sustained airway relaxation.
LOE Approaching
As a product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team will focus on lifecycle extension and defending market position against newer fixed-dose combinations.
Mechanism of Action
LABA. In vitro studies show salmeterol to be at least 50 times more selective for beta 2 -adrenoceptors than albuterol. Although beta 2 -adrenoceptors are the predominant adrenergic receptors in bronchial smooth muscle and beta 1 -adrenoceptors are the predominant receptors in the heart, there are…
Indications (6)
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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.