Vigpoder FDA Approval History
Last updated by Judith Stewart, BPharm on May 12, 2024.
FDA Approved: Yes (First approved June 24, 2022)
Brand name: Vigpoder
Generic name: vigabatrin
Dosage form: for Oral Solution
Company: Pyros Pharmaceuticals, Inc.
Treatment for: Seizures, Infantile Spasms
Vigpoder (vigabatrin) is an anticonvulsant used for the treatment of refractory complex partial seizures and infantile spasms.
- Vigpoder is indicated for the treatment of:
- Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments. Vigpoder is not indicated as a first line agent.
- Infantile Spasms as monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. - Vigpoder is therapeutically equivalent to Sabril (vigabatrin) for oral solution.
- Vigpoder is supplied as packets containing vigabatrin 500 mg granular powder which is reconstituted into an oral solution with a concentration of 50 mg/mL.
- Vigpoder carries a Boxed Warning for permanent vision loss. Vigpoder can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, Vigpoder may also decrease visual acuity. Vigpoder is available only through a restricted program called the Vigabatrin REMS Program.
- Warnings and precautions associated with Vigpoder include abnormal MRI signal changes and intramyelinic edema, suicidal behavior and ideation, anemia, and somnolence and fatigue.
- Common adverse reactions in patients with Refractory Complex Partial Seizures:
- Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue.
- Pediatric patients (3 to 16 years of age): weight gain.
Common adverse reactions in patients with Infantile Spasms includes somnolence, bronchitis, ear infection, and acute otitis media.
Development timeline for Vigpoder
| Date | Article |
|---|---|
| Apr 1, 2024 | Approval Pyros Pharmaceuticals Announces Vigpoder (vigabatrin) is Now Available |
Further information
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