ACTOS
Details
- Status
- Prescription
- First Approved
- 1999-07-15
- Routes
- ORAL
- Dosage Forms
- TABLET
ACTOS Approval History
What ACTOS Treats
1 indicationsACTOS is approved for 1 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 Diabetes
ACTOS Boxed Warning
CONGESTIVE HEART FAILURE • Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . • After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOS must be consid...
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . • After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOS must be considered. • ACTOS is not recommended in patients with symptomatic heart failure. • Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated [see Contraindications (4) and Warnings and Precautions (5.1) ] . WARNING: CONGESTIVE HEART FAILURE See full prescribing information for complete boxed warning. • Thiazolidinediones, including ACTOS, cause or exacerbate congestive heart failure in some patients. ( 5.1 ) • After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOS must be considered. ( 5.1 ) • ACTOS is not recommended in patients with symptomatic heart failure. ( 5.1 ) • Initiation of ACTOS in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated. ( 4 , 5.1 )
Drugs Similar to ACTOS
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
ACTOS FDA Label Details
ProIndications & Usage
FDA Label (PDF)Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies ] . Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. ACTOS should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions ] . ACTOS is a thiazolidinedione and an agonist for peroxisome proliferato...
WARNING: CONGESTIVE HEART FAILURE • Thiazolidinediones, including ACTOS ® , cause or exacerbate congestive heart failure in some patients [see Warnings and Precautions (5.1) ] . • After initiation of ACTOS, and after dose increases, monitor patients carefully for signs and symptoms of heart failure ...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.