GLATIRAMER ACETATE
Details
- Status
- Prescription
- First Approved
- 2017-10-03
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
GLATIRAMER ACETATE Approval History
What GLATIRAMER ACETATE Treats
4 indicationsGLATIRAMER ACETATE is approved for 4 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
- Clinically Isolated Syndrome
- Relapsing-Remitting Disease
- Secondary Progressive Disease
GLATIRAMER ACETATE Boxed Warning
BOXED WARNING WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with Glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. ● Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Pro...
BOXED WARNING WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with Glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. ● Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction; instruct them to seek immediate medical care should these symptoms occur. Prompt identification of anaphylaxis is important to avoid a delay in treatment [see Warnings and Precautions ( 5.1 )] . ● Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to Glatiramer acetate injection, including anaphylaxis. If an anaphylactic reaction occurs, treatment with Glatiramer acetate injection must be immediately discontinued. Unless a clear alternative etiology is identified, Glatiramer acetate injection must be permanently discontinued [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . WARNING: ANAPHYLACTIC REACTIONS See full prescribing information for complete boxed warning. Life-threatening and fatal anaphylaxis, which can occur at any time following initiation of therapy (from as early as after the first dose, up to years after initiation of treatment), has been reported in patients receiving Glatiramer acetate injection. ● Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction. Prompt identification of anaphylaxis is important to avoid a delay in treatment ( 5.1 ). ● Glatiramer acetate injection is contraindicated in patients with a history of hypersensitivity reactions to Glatiramer acetate injection, including anaphylaxis ( 4 ).
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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.
GLATIRAMER ACETATE FDA Label Details
ProIndications & Usage
Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Glatiramer acetate injection is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults .
BOXED WARNING WARNING: ANAPHYLACTIC REACTIONS Cases of life-threatening and fatal anaphylaxis have been reported with Glatiramer acetate injection. Anaphylaxis can occur at any time following initiation of therapy, from as early as after the first dose, up to years following initiation of therapy. ●...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.