NDAINHALATIONPOWDER
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEREVENT (salmeterol xinafoate) is a long-acting beta-2 agonist (LABA) inhaled powder used for maintenance treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by binding to beta-2 adrenergic receptors in airway smooth muscle, causing bronchodilation and sustained airway relaxation for up to 12 hours.
LOE Approaching
With LOE approaching, the SEREVENT brand team is likely in transition mode with focus shifting toward line extension strategy or defensive positioning rather than growth investment.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.
Started Aug 2026
188 enrolled
Asthma
Bioequivalence Study for Fluticasone Propionate 500 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Started Aug 2023
34 enrolled
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Started Aug 2023
34 enrolled
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 100 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Started Feb 2023
34 enrolled
Bioequivalence
Bioequivalence Study of Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers
Started Oct 2021
18 enrolled
BioequivalenceAsthma
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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.