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Generic Budesonide/Formoterol Fumarate Dihydrate
Generic Budesonide/Formoterol Fumarate Dihydrate is a Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) Small molecule drug developed by Actavis Inc.. It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
Budesonide/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle.
Budesonide/formoterol combines a corticosteroid that reduces airway inflammation with a long-acting beta-2 agonist that relaxes airway smooth muscle. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Generic Budesonide/Formoterol Fumarate Dihydrate |
|---|---|
| Sponsor | Actavis Inc. |
| Drug class | Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) |
| Target | Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol) |
| Modality | Small molecule |
| Therapeutic area | Respiratory/Pulmonology |
| Phase | Phase 3 |
Mechanism of action
Budesonide is an inhaled corticosteroid that suppresses inflammatory responses in the airways by binding glucocorticoid receptors, reducing mucus production and airway edema. Formoterol is a long-acting beta-2 adrenergic agonist (LABA) that binds beta-2 receptors on airway smooth muscle, causing bronchodilation and improved airflow. Together, they provide both anti-inflammatory and bronchodilatory effects for sustained asthma and COPD control.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Nervousness/anxiety
- Palpitations
- Oral candidiasis
- Dysphonia
Key clinical trials
- Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients (PHASE3)
- Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Generic Budesonide/Formoterol Fumarate Dihydrate CI brief — competitive landscape report
- Generic Budesonide/Formoterol Fumarate Dihydrate updates RSS · CI watch RSS
- Actavis Inc. portfolio CI
Frequently asked questions about Generic Budesonide/Formoterol Fumarate Dihydrate
What is Generic Budesonide/Formoterol Fumarate Dihydrate?
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Related
- Drug class: All Inhaled corticosteroid/long-acting beta-2 agonist combination (ICS/LABA) drugs
- Target: All drugs targeting Glucocorticoid receptor (budesonide); beta-2 adrenergic receptor (formoterol)
- Manufacturer: Actavis Inc. — full pipeline
- Therapeutic area: All drugs in Respiratory/Pulmonology
- Indication: Drugs for Asthma maintenance therapy
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Compare: Generic Budesonide/Formoterol Fumarate Dihydrate vs similar drugs
- Pricing: Generic Budesonide/Formoterol Fumarate Dihydrate cost, discount & access