ABRAXANE
Details
- Status
- Prescription
- First Approved
- 2005-01-07
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ABRAXANE Approval History
What ABRAXANE Treats
5 FDA approvalsOriginally approved for its first indication in 2005 . Covers 5 distinct patient populations.
- Other (5)
ABRAXANE Boxed Warning
SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. • Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxe...
WARNING: SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. • Perform frequent complete blood cell counts on all patients receiving ABRAXANE [see Warnings and Precautions (5.1 , 5.3) ]. WARNING: SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning . • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 . ( 4 ) • Monitor for neutropenia, which may be severe and result in infection or sepsis. ( 5.1 , 5.3 ) • Perform frequent complete blood cell counts on all patients receiving ABRAXANE. ( 5.1 , 5.3 )
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.
ABRAXANE FDA Label Details
ProIndications & Usage
FDA Label (PDF)ABRAXANE is a microtubule inhibitor indicated for the treatment of: • Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. • Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. • Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcit...
WARNING: SEVERE MYELOSUPPRESSION • Do not administer ABRAXANE therapy to patients with baseline neutrophil counts of less than 1,500 cells/mm 3 [see Contraindications (4) ]. • Monitor for neutropenia, which may be severe and result in infection or sepsis [see Warnings and Precautions (5.1 , 5.3) ]. ...
ABRAXANE Patents & Exclusivity
Patents (14 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.