PERTOFRANE (desipramine hydrochloride) · Sanofi
PERTOFRANE is FDA-approved to treat 1 condition (same as DESIPRAMINE HYDROCHLORIDE).
Details
- Status
- Discontinued
- First Approved
- 1968-04-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE
PERTOFRANE Approval History
What PERTOFRANE Treats
1 indicationsPERTOFRANE is approved for 1 conditions since its original approval in 1968. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Depression
Same approved indications as DESIPRAMINE HYDROCHLORIDE (same active ingredient).
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00964886 results posted | NURA-019-09S | Ph 2 | completed | Efficacy of Antidepressants in Chronic Back Pain |
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.
PERTOFRANE FDA Label Details
Indications & Usage
PERTOFRANE is FDA-approved to treat 1 condition — same approved indications as DESIPRAMINE HYDROCHLORIDE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.