TEPYLUTE
Details
- Status
- Prescription
- First Approved
- 2024-06-25
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
TEPYLUTE Approval History
What TEPYLUTE Treats
2 indicationsTEPYLUTE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adenocarcinoma of the Breast
- Adenocarcinoma of the Ovary
TEPYLUTE Boxed Warning
SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPYLUTE may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. [see Warnings and Precautions ( 5.1 )]. TEPYLUTE should be considered potentially carcinogenic in humans [see Warnings and Precautions ( 5.7 )]. WARNING: SEVERE MYELOSUPPRESSION and CARCINOGENICITY See full prescribing information for complete boxed warning May cause severe marrow suppre...
WARNING: SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPYLUTE may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. [see Warnings and Precautions ( 5.1 )]. TEPYLUTE should be considered potentially carcinogenic in humans [see Warnings and Precautions ( 5.7 )]. WARNING: SEVERE MYELOSUPPRESSION and CARCINOGENICITY See full prescribing information for complete boxed warning May cause severe marrow suppression or ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters ( 5.1 ). Potentially carcinogenic in humans ( 5.7 ).
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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.
TEPYLUTE FDA Label Details
ProIndications & Usage
FDA Label (PDF)TEPYLUTE is an alkylating drug indicated for treatment of adenocarcinoma of the breast or ovary. 1.1 Adenocarcinoma of the Breast or Ovary TEPYLUTE is indicated for treatment of adenocarcinoma of the breast or ovary.
WARNING: SEVERE MYELOSUPPRESSION and CARCINOGENICITY TEPYLUTE may cause severe marrow suppression, and high doses may cause marrow ablation with resulting infection or bleeding. Monitor hematologic laboratory parameters. [see Warnings and Precautions ( 5.1 )]. TEPYLUTE should be considered potential...
TEPYLUTE Patents & Exclusivity
Patents (4 active)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.