Data updated: Mar 10, 2026
PREGABALIN
PREGABALIN
Approved 2019-07-19
36
Indications
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-07-19
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, EXTENDED RELEASE, SOLUTION
Companies
MACLEODS PHARMS LTD TORRENT ALKEM LABS LTD ALVOGEN ADAPTIS Cipla ESKAYEF STRIDES PHARMA AIPING PHARM INC Novartis Apotex Teva RISING PHARMOBEDIENT NOVEL LABS INC Aurobindo Pharma ANDA REPOSITORY CREEKWOOD PHARMS Lupin WATSON LABS INC YILING Sun Pharma ALEMBIC AMNEAL PHARMS CO SOMERSET THERAPS LLC INVAGEN PHARMS CHARTWELL RX RUBICON RESEARCH CADILA PHARMS LTD ZYDUS PHARMS MSN CHANGZHOU PHARM SCIEGEN PHARMS FOURRTS LABS PRINSTON INC JUBILANT GENERICS Dr. Reddy's HETERO LABS LTD III REGCON HOLDINGS EPIC PHARMA LLC
Active Ingredient: PREGABALIN
Website: ↗
PREGABALIN Approval History
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What PREGABALIN Treats
36 FDA approvalsOriginally approved for its first indication in 2019 . Covers 36 distinct patient populations.
- Other (36)
Other
(36 approvals)- • Approved indication (Jul 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Sep 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Nov 2019)
- • Approved indication (Dec 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Mar 2020)
- • Approved indication (Mar 2020)
- • Approved indication (Jul 2020)
- • Approved indication (Apr 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Feb 2022)
- • Approved indication (Mar 2022)
- • Approved indication (Mar 2022)
- • Approved indication (May 2022)
- • Approved indication (Jul 2022)
- • Approved indication (Aug 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Sep 2022)
- • Approved indication (Dec 2022)
- • Approved indication (Mar 2023)
- • Approved indication (Apr 2023)
- • Approved indication (Jun 2023)
- • Approved indication (Jul 2023)
- • Approved indication (Jan 2024)
- • Approved indication (May 2024)
- • Approved indication (Nov 2024)
- • Approved indication (Jan 2025)
- • Approved indication (Feb 2025)
- • Approved indication (May 2025) New
- • Approved indication (Feb 2026) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
PREGABALIN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.