Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Comprehensive Report on Albuterol Sulfate/Fluticasone Propionate (TEV-'248, Teva Branded Pharmaceutical Industries)
1. Introduction
The management of asthma, a chronic inflammatory disease of the airways, continues to evolve with the development of new therapeutic strategies and drug delivery systems. One such investigational product is a fixed-dose combination of albuterol sulfate and fluticasone propionate, identified by the development codes TEV-'248 and TEV-56248, from Teva Branded Pharmaceutical Industries. This combination aims to provide both rapid symptom relief and address underlying inflammation, aligning with current global asthma management guidelines. TEV-'248 is delivered via a multi-dose dry powder inhaler (MDPI), potentially incorporating Teva's Digihaler technology, and is intended for use as a rescue medication in asthma.[1] This report provides a comprehensive overview of albuterol sulfate/fluticasone propionate (TEV-'248), detailing its individual components, the rationale for the combination, its pharmacokinetic profile, the ongoing clinical development program, anticipated safety and tolerability, regulatory standing, and its position within Teva's existing respiratory product portfolio.
2. Components: Albuterol Sulfate and Fluticasone Propionate
2.1. Albuterol Sulfate
Albuterol sulfate is a well-established short-acting beta$_2$-adrenergic agonist (SABA).2
Therapeutic Class and Mechanism of Action: Albuterol belongs to the family of medicines known as adrenergic bronchodilators.2 It acts selectively on beta$_2$-adrenergic receptors in the lungs, leading to relaxation of bronchial smooth muscle, and thereby causing bronchodilation.3 This action helps to relieve cough, wheezing, and dyspnea by increasing airflow through the bronchial tubes.2
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/29 | Phase 3 | Recruiting | |||
2024/03/04 | Phase 1 | Completed | |||
2023/09/25 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.