COSELA
Details
- Status
- Prescription
- First Approved
- 2021-02-12
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
COSELA Approval History
What COSELA Treats
2 indicationsCOSELA is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelosuppression
- Small Cell Lung Cancer
COSELA Competitors
Pro3 other drugs also target CDK4. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CDK4). Earlier expiry dates signal biosimilar/generic opportunities.
Drugs Similar to COSELA
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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.
COSELA FDA Label Details
ProIndications & Usage
FDA Label (PDF)COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
COSELA Patents & Exclusivity
Patents (17 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.