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Data updated: Mar 10, 2026

OZOBAX DS

BACLOFEN GABA A Agonists
Neurology Approved 2019-09-18
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-09-18
Routes
ORAL
Dosage Forms
SOLUTION

Companies

METACEL PHARMS LLC
Active Ingredient: BACLOFEN

OZOBAX DS Approval History

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What OZOBAX DS Treats

8 indications

OZOBAX DS is approved for 8 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Spasticity
  • Multiple Sclerosis
  • Flexor Spasms
  • Pain
  • Clonus
  • Muscular Rigidity
  • Spinal Cord Injuries
  • Spinal Cord Disease
Source: FDA Label

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Key Completed Trials

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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.

OZOBAX DS FDA Label Details

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Indications & Usage

FDA Label (PDF)

OZOBAX DS is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. OZOBAX DS may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use OZOBAX DS is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. OZOBAX DS is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms ...

OZOBAX DS Patents & Exclusivity

Latest Patent: Aug 2039

Patents (1 active)

US10610502 Expires Aug 30, 2039
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA208193 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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