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Data updated: Mar 10, 2026

BACLOFEN

BACLOFEN GABA A Agonists
Neurology Approved 1988-07-21
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
35
Indications
--
Phase 3 Trials
37
Years on Market

Details

Status
Prescription
First Approved
1988-07-21
Routes
ORAL, INTRATHECAL
Dosage Forms
TABLET, INJECTABLE, SUSPENSION, SOLUTION

Companies

LANNETT CO INC MANKIND PHARMA RISING IVAX SUB TEVA PHARMS OXFORD PHARMS SOMERSET THERAPS LLC USL PHARMA WATSON LABS NORTHSTAR HLTHCARE RUBICON RESEARCH MAIA PHARMS INC Aurobindo Pharma PH HEALTH AMNEAL MICRO LABS PHARMOBEDIENT ANI PHARMS Sun Pharma IMPAX HERITAGE ANDAS 5 HOLDING HIBROW HLTHCARE ZYDUS LIFESCIENCES UNICHEM REGCON HOLDINGS Teva YILING
Active Ingredient: BACLOFEN

BACLOFEN Approval History

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What BACLOFEN Treats

4 indications

BACLOFEN is approved for 4 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Spasticity
  • Multiple Sclerosis
  • Spinal Cord Injury
  • Spinal Cord Disease
Source: FDA Label

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

BACLOFEN FDA Label Details

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Indications & Usage

FDA Label (PDF)

Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in str...

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Data Sources

FDA Approval: ANDA077241 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.