ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (hydralazine hydrochloride) · INGENUS PHARMS LLC
Isosorbide dinitrate and hydralazine hydrochloride is indicated as an adjunct to standard therapy for the treatment of heart failure in self-identified black patients. It is used to improve survival, prolong the time to heart failure-related hospitalization, and improve patient-reported functional status. There is limited clinical experience regarding its use in patients with NYHA class IV heart failure.
How ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE Works
The exact mechanism underlying the clinical benefits of this combination in heart failure has not been fully established. Isosorbide dinitrate is a vasodilator that affects both arteries and veins by releasing nitric oxide, which activates guanylyl cyclase and leads to vascular smooth muscle relaxation. Hydralazine hydrochloride is a selective arterial vasodilator. Evidence suggests that hydralazine may also mitigate the development of nitrate tolerance, potentially preserving the long-term efficacy of the isosorbide dinitrate component.
Details
- Status
- Prescription
- First Approved
- 2022-04-06
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE Approval History
What ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE Treats
1 indicationsISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE Competitive Set
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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.
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE FDA Label Details
Indications & Usage
Isosorbide dinitrate and hydralazine hydrochloride tablets is a combination of isosorbide dinitrate, a nitrate vasodilator, and hydralazine hydrochloride, an arteriolar vasodilator, indicated for: ● the treatment of heart failure as an adjunct therapy to standard therapy in self-identified black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status Limitations of use: ● There is little experience in patients with NYHA class IV heart failure 1.1 Treatment of Heart Failure in Self-identified Black Patients Isosorbide din...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.