NDAINHALATIONAEROSOL, METERED
Approved
Jul 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
SYMBICORT (budesonide and formoterol fumarate dihydrate) by AstraZeneca is corticosteroid hormone receptor agonists [moa]. First approved in 2006.
Drug data last refreshed 3d ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYMBICORT is a combination inhaled corticosteroid (budesonide) and long-acting beta-2 agonist (formoterol fumarate dihydrate) approved by the FDA on July 21, 2006. Administered via metered-dose aerosol inhalation, it works by activating corticosteroid hormone receptors to reduce airway inflammation while formoterol provides bronchodilation. The product is indicated for maintenance treatment of asthma and COPD, serving as a foundational therapy in the inhaled combination market. SYMBICORT is positioned as a widely-used, well-established maintenance inhaler in respiratory disease management.
$2.0BPart D
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
Started Jul 2018
750 enrolled
Chronic Obstructive Pulmonary Disease
A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
Started Jun 2017
99 enrolled
AsthmaCOPD
Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants
Started Jan 2017
1,714 enrolled
Asthma
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
Started Dec 2016
990 enrolled
COPD (Chronic Obstructive Pulmonary Disease)
A Study to Assess How Much Drug Reaches the Blood When Given From Symbicort pMDI With Spacer Compared to That of Symbicort pMDI Without Spacer in Healthy Volunteers
Started Nov 2016
50 enrolled
Study is Being Conducted in Healthy Volunteers
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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.