Vigabatrin brand names and generics
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Short answer: in the US, vigabatrin is sold as Sabril (500 mg tablets and 500 mg powder packets), as Vigafyde (a ready-to-use liquid, 100 mg per mL), and as generics such as Vigadrone and Vigpoder.1,2,3 Every product contains the same medicine, carries the same boxed warning about permanent vision loss, and is dispensed only through the Vigabatrin REMS.4,5
What differs between them is the form, how each dose is prepared, and who it is labeled for. For a practical comparison of the forms, see liquid vs powder.
US vigabatrin products
| Product | Form | Strength | Labeled for | FDA application |
|---|---|---|---|---|
| Sabril tablets | Film-coated, scored tablet | 500 mg | Refractory complex partial seizures, age 2 and up | NDA 0204271 |
| Sabril for oral solution | Powder packets, mixed with water | 500 mg per packet | Infantile spasms, 1 month to 2 years; refractory complex partial seizures, age 2 and up | NDA 0220061 |
| Vigafyde | Ready-to-use oral solution | 100 mg per mL, 150 mL bottle | Infantile spasms only, 1 month to 2 years | NDA 2176842 |
| Vigadrone | Powder packets, mixed with water | 500 mg per packet | See its label | ANDA 2101963 |
| Vigpoder | Generic vigabatrin | 500 mg | See its label | ANDA 2149613 |
| Other generics | Powder packets or tablets | 500 mg | See each label | Several ANDAs3 |
Sabril
Sabril is the original brand name. Its tablets and its powder for oral solution were both approved on 21 August 2009. The application holder is Lundbeck.1
- Tablets: 500 mg, film-coated and scored, in bottles of 100.5 See tablets.
- Powder for oral solution: 500 mg packets, 50 to a package. Each dose is mixed with 10 mL of water per packet, used straight away, and the rest thrown out.6 See powder sachets.
The powder is labeled for infantile spasms from 1 month to 2 years and, as an add-on treatment, for refractory complex partial seizures from age 2.6
Vigafyde
Vigafyde is a ready-to-use oral solution, 100 mg per mL, approved on 17 June 2024. The application holder is Pyros.2 It comes in a 150 mL bottle, needs no mixing, and is kept for up to 90 days after opening.4
Vigafyde is labeled only for infantile spasms in babies 1 month to 2 years old. It is not approved for refractory complex partial seizures or for adults.4 Its approval was based on comparing its composition with vigabatrin powder solution, not on new efficacy trials.4
In the FDA's records, Vigafyde was the only vigabatrin product listed as a ready-to-use solution. Every generic was a powder or a tablet.3
Because it is twice as concentrated as mixed powder, the same number of mL gives twice the dose. The label warns prescribers, pharmacists and caregivers to check the volume when switching.4
Vigadrone
Vigadrone is a generic vigabatrin powder for oral solution, approved on 21 June 2018 under ANDA 210196. DailyMed now lists Upsher-Smith as its labeler.3 It comes in 500 mg packets in cartons of 50, and it is mixed exactly like Sabril powder: 10 mL of water per packet, 50 mg per mL, each dose made fresh and the rest discarded.7
A 2025 lab study by the powder's makers found Vigadrone stayed stable for 48 hours in the fridge when mixed in water, juice, milk or formula. The label still says water only.8
Vigpoder and other generics
Vigpoder is a generic vigabatrin approved under ANDA 214961; the application holder is Pyros. Teva, Amneal, Dr. Reddy's, Zydus and others hold approvals for generic vigabatrin powder packets or 500 mg tablets.3
What generic means here
A generic is approved through an abbreviated new drug application (ANDA). It contains the same active ingredient, vigabatrin, in the same 500 mg strength as the brand product it copies.3 Generic and brand powders are mixed the same way.6,7 Which product you receive can depend on your insurance and pharmacy; see cost.
Reading the FDA labels
The full prescribing information is the most reliable source for any product. Current versions are on DailyMed:
We also keep copies of two FDA labels as PDFs: the Vigafyde label as first approved in 2024, and the Sabril label covering tablets and powder. Labels are revised over time, so check DailyMed for the latest wording. For label dosing in mg and mL, see dosage; for the safety program that applies to every brand, see REMS.
Common questions
What is the brand name of vigabatrin?
In the US, the original brand is Sabril, sold as 500 mg tablets and 500 mg powder packets since 2009. Vigafyde is a newer brand, approved in 2024, and is a ready-to-use liquid. Vigadrone and Vigpoder are generic versions, and several other companies make generics.
Is Vigadrone the same as Sabril?
Vigadrone is a generic vigabatrin powder for oral solution, approved in 2018. It comes in 500 mg packets in cartons of 50 and is mixed the same way as Sabril powder: 10 mL of water per packet, made fresh for each dose.
Is there a generic of Vigafyde?
In FDA records checked in October 2026, Vigafyde was the only ready-to-use vigabatrin solution. All generic vigabatrin products were powder packets or tablets.
Do all vigabatrin brands carry the vision-loss warning?
Yes. Every vigabatrin product contains the same medicine, carries the boxed warning about permanent vision loss and is available only through the Vigabatrin REMS program.
References
- 1.Drugs@FDA: NDA 020427 SABRIL tablet 500 mg and NDA 022006 SABRIL for oral solution 500 mg/packet, Lundbeck. Both approved 2009-08-21. Source
- 2.Drugs@FDA (openFDA API): NDA 217684, VIGAFYDE (vigabatrin) oral solution 100 mg/mL, sponsor Pyros Pharms; original approval 2024-06-17. Source
- 3.Drugs@FDA (openFDA): numerous ANDAs for vigabatrin for oral solution 500 mg/packet and tablets 500 mg. Examples: VIGADRONE ANDA 210196 (approved 2018-06-21; DailyMed labeler now Upsher-Smith); VIGPODER ANDA 214961 (Pyros); Teva, Amneal, Dr. Reddy's, Zydus and others. VIGAFYDE was the only vigabatrin "SOLUTION" (ready-to-use) dosage form in the results. Source
- 4.VIGAFYDE (vigabatrin) oral solution prescribing information, revised 11/2025. Source
- 5.SABRIL (vigabatrin) tablets prescribing information, revised 10/2021. Source
- 6.SABRIL (vigabatrin) for oral solution prescribing information, revised 10/2021. Source
- 7.VIGADRONE (vigabatrin) for oral solution, revised 12/2025, Upsher-Smith. Source
- 8.Zachman M, Gong L, An L, Halvorsen MB. Dissolution and stability of vigabatrin powder in water, fruit juice, milk, and infant formula. Epilepsy Behav Rep. 2025;31:100816. PMID 40838171 · DOI 10.1016/j.ebr.2025.100816 PubMed · DOI