NDAINHALATIONPOWDER1 Generic Approved
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
6
Data completeness
3/8 — Basic
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADVAIR DISKUS 250/50 is a combination inhaled powder containing fluticasone propionate (corticosteroid) and salmeterol (long-acting beta-2 agonist) for maintenance treatment of asthma. It works by reducing airway inflammation via glucocorticoid receptor binding and relaxing bronchial smooth muscle through beta-2 adrenergic stimulation. The dual mechanism provides both anti-inflammatory and bronchodilatory effects.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (45/100); brand defense and pipeline transition initiatives will drive team priorities.
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 (6)
Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma
Started Dec 2018
999 enrolled
Asthma
A Study in Patients With Moderate Asthma to Compare Pharmacokinetics and Pharmacodynamic Effects of Fluticasone Propionate and Salmeterol Delivered Via the ROTAHALER® Inhaler Relative to the DISKUS® Inhaler
Started Oct 2014
0Asthma
A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer
Started Jan 2014
21 enrolled
Asthma
A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Combination Dry Powder of Fluticasone Propionate and Salmeterol (FSC) 250/50 Microgram (mcg) Twice Daily (BID) in Adults and Adolescents With Asthma
Started Nov 2013
124 enrolled
Asthma
Pharmacokinetic and Pharmacodynamic (PK and PD) Study of Fluticasone Propionate and Salmeterol Combination Product Delivered in a Capsule-based Inhaler and in a Multi-dose Dry Powder Inhaler in Moderate Asthma Patients and Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients.
Started Oct 2010
60 enrolled
Asthma
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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.