GENERLAC
Details
- Status
- Prescription
- First Approved
- 1996-10-31
- Routes
- ORAL, RECTAL
- Dosage Forms
- SOLUTION
GENERLAC Approval History
What GENERLAC Treats
1 indicationsGENERLAC is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatic Encephalopathy
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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.
GENERLAC FDA Label Details
ProIndications & Usage
For the prevention and treatment of portal-systemic encephalopathy, including the stages of hepatic pre-coma and coma. Controlled studies have shown that lactulose solution therapy reduces the blood ammonia levels by 25 to 50%; this is generally paralleled by an improvement in the patients' mental state and by an improvement in EEG patterns. The clinical response has been observed in about 75% of patients, which is at least as satisfactory as that resulting from neomycin therapy. An increase in patients' protein tolerance is also frequently observed with lactulose solution therapy. In the trea...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.