TUDORZA PRESSAIR
Details
- Status
- Prescription
- First Approved
- 2012-07-23
- Routes
- INHALATION
- Dosage Forms
- POWDER, METERED
TUDORZA PRESSAIR Approval History
What TUDORZA PRESSAIR Treats
1 indicationsTUDORZA PRESSAIR is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Obstructive Pulmonary Disease
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TUDORZA PRESSAIR FDA Label Details
ProIndications & Usage
FDA Label (PDF)TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TUDORZA PRESSAIR is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
TUDORZA PRESSAIR Patents & Exclusivity
Patents (2 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.