PRASUGREL
Details
- Status
- Prescription
- First Approved
- 2017-07-12
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PRASUGREL Approval History
What PRASUGREL Treats
7 indicationsPRASUGREL is approved for 7 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombotic Cardiovascular Events
- Acute Coronary Syndrome
- Unstable Angina
- Non-ST-Elevation Myocardial Infarction
- ST-Elevation Myocardial Infarction
- Myocardial Infarction
- Stroke
PRASUGREL Boxed Warning
BLEEDING RISK Prasugrel can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindications (4.1 , 4.2) ] . In patients ≥75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations ...
WARNING: BLEEDING RISK Prasugrel can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindications (4.1 , 4.2) ] . In patients ≥75 years of age, prasugrel is generally not recommended, because of the increased risk of fatal and intracranial bleeding and uncertain benefit, except in high-risk situations (patients with diabetes or a history of prior myocardial infarction [MI]) where its effect appears to be greater and its use may be considered [see Use in Specific Populations (8.5) ] . Do not start prasugrel in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue prasugrel at least 7 days prior to any surgery [see Warnings and Precautions (5.2) ] . Additional risk factors for bleeding include: body weight <60 kg, propensity to bleed, concomitant use of medications that increase the risk of bleeding (e.g., warfarin, heparin, fibrinolytic therapy, chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs]) [see Warnings and Precautions (5.1) ] . Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of prasugrel [see Warnings and Precautions (5.1) ] . If possible, manage bleeding without discontinuing prasugrel. Discontinuing prasugrel, particularly in the first few weeks after acute coronary syndrome, increases the risk of subsequent cardiovascular (CV) events [see Warnings and Precautions (5.3) ] . WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Prasugrel can cause significant, sometimes fatal, bleeding (5.1 , 5.2 , 6.1) . Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack or stroke (4
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Key Completed Trials
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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.
PRASUGREL FDA Label Details
ProIndications & Usage
FDA Label (PDF)Prasugrel tablets are a P2Y 12 platelet inhibitor indicated for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndrome who are to be managed with percutaneous coronary intervention (PCI) as follows: Patients with unstable angina or non-ST-elevation myocardial infarction (NSTEMI) . Patients with ST-elevation myocardial infarction (STEMI) when managed with either primary or delayed PCI . 1.1 Acute Coronary Syndrome Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients wi...
WARNING: BLEEDING RISK Prasugrel can cause significant, sometimes fatal, bleeding [see Warnings and Precautions (5.1 , 5.2) and Adverse Reactions (6.1) ] . Do not use prasugrel in patients with active pathological bleeding or a history of transient ischemic attack (TIA) or stroke [see Contraindicati...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.