NDAINHALATIONPOWDER2 Generics Approved
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
5
Data completeness
3/8 — Basic
Drug data last refreshed 16h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADVAIR DISKUS 100/50 is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (salmeterol) delivered as a dry powder formulation. It is indicated for maintenance treatment of asthma and COPD in patients requiring both anti-inflammatory and bronchodilator therapy. The dual mechanism provides sustained airway relaxation and inflammation control.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure (60/100), signaling potential team restructuring and shift toward lifecycle management and generic transition planning.
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 (5)
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
Worked on ADVAIR DISKUS 100/50 at GSK? Share your interview experience or compensation data (+7 days Pro)
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.