ALPROSTADIL
Details
- Status
- Prescription
- First Approved
- 1998-01-20
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ALPROSTADIL Approval History
What ALPROSTADIL Treats
8 indicationsALPROSTADIL is approved for 8 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pulmonary Atresia
- Pulmonary Stenosis
- Tricuspid Atresia
- Tetralogy of Fallot
- Interruption of the Aortic Arch
- Coarctation of the Aorta
- Transposition of the Great Vessels
- Congenital Heart Defects
ALPROSTADIL Boxed Warning
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used where ventilatory assistance is immediately available....
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and alprostadil injection should be used where ventilatory assistance is immediately available.
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Key Completed Trials
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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.
ALPROSTADIL FDA Label Details
ProIndications & Usage
Alprostadil injection, USP is indicated for palliative, not definitive, therapy to temporarily maintain the patency of the ductus arteriosus until corrective or palliative surgery can be performed in neonates who have congenital heart defects and who depend upon the patent ductus for survival. Such congenital heart defects include pulmonary atresia, pulmonary stenosis, tricuspid atresia, tetralogy of Fallot, interruption of the aortic arch, coarctation of the aorta, or transposition of the great vessels with or without other defects. In infants with restricted pulmonary blood flow, the increas...
WARNING Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with alprostadil injection. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be moni...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.