Prescription medicine
Foscarbidopa and foslevodopa Brand names: Vyalev
Foscarbidopa and foslevodopa (Vyalev) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the foscarbidopa and foslevodopa FDA label on DailyMed (effective March 19, 2026, AbbVie Inc.); the NDA 216962 record on Drugs@FDA; every foscarbidopa and foslevodopa label on DailyMed.
Highlights of the record
FDA label of March 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD).
Forms and strengths
- 12 mg/ml / 240 mg/ml
Injection.
On the market
- Earliest approval on file
- October 16, 2024 Vyalev, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 10, 2040 Vyalev injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,378 through July 30, 2026
What is foscarbidopa and foslevodopa used for?
From the label: indications and usageVYALEV is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). VYALEV is a combination of foscarbidopa (an aromatic amino acid decarboxylation inhibitor) and foslevodopa (an aromatic amino acid) indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Conditions named in the indications of foscarbidopa and foslevodopa's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Vyalev), AbbVie Inc., effective March 19, 2026 (SPL set 28e806e4-951c-40a9-9f0c-d0929caf054c), via openFDA; the full label on DailyMed
What does the patient leaflet for foscarbidopa and foslevodopa say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VYALEV?VYALEV may cause serious side effects, including: Falling asleep during activities of daily living and somnolence Hallucinations/psychosis, or confusion Impulse control, compulsive behaviors Infusion site reactions and infections Cardiovascular ischemic events Some of these problems may require discussion with your healthcare provider. See “What are the possible side effects of VYALEV?” for more information about side effects.
From the patient leaflet: What should I avoid while using VYALEV?Do not drive, operate machinery, or do other activities until you know how VYALEV affects you. Sleepiness and falling asleep suddenly caused by VYALEV can happen as late as 1 year after you start your treatment.
From the patient leaflet: How should I store VYALEV?Keep the vials in the outer carton to protect the vials from breaking. Store VYALEV in the refrigerator between 36°F to 46°F (2°C to 8°C). Record the date when VYALEV is first removed from the refrigerator in the space provided on the carton. VYALEV may be stored at room temperature up to a maximum of 86°F (30°C) for a single period of up to 28 days. After VYALEV has been stored at room temperature, do not return the medicine to the refrigerator. If stored at room temperature, throw away (dispose of) VYALEV if not used within 28 days. Do not freeze. Do not shake. If VYALEV is stored in the refrigerator, take one VYALEV vial out of the carton and out of the refrigerator 30 minutes before use. Use the VYALEV at room temperature or you may not get the right amount of the medicine. Keep VYALEV and all medicines out of the reach of children.
Source: FDA drug label (Vyalev), AbbVie Inc., effective March 19, 2026 (SPL set 28e806e4-951c-40a9-9f0c-d0929caf054c), via openFDA; the full label on DailyMed
Is there a generic for foscarbidopa and foslevodopa (Vyalev)?
No generic foscarbidopa and foslevodopa is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Vyalev injection: the compound patent runs to October 21, 2035, and the last listed entry to June 10, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the foscarbidopa and foslevodopa label say about other medicines?
The foscarbidopa and foslevodopa label names 10 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbidopa | warnings and precautions | If the cannula is removed for an infection, either a new canula should be placed at a new infusion site or, in the event of a prolonged interruption, the patient should be prescribed an oral carbidopa and levodopa product until they are able to resume VYALEV [see Dosage and Administration ( 2.4 , 2.5 )]. |
| Carbidopa and levodopa | warnings and precautions | Seizures associated with vitamin B6 deficiency have been reported in the postmarketing setting in patients taking carbidopa/levodopa. |
| Isoniazid | drug interactions | Dosage adjustment of the antihypertensive drug may be needed. ( 7.2 ) Dopamine D2 receptor antagonists and isoniazid may reduce the effectiveness of VYALEV. |
| Levodopa | warnings and precautions | Hallucinations associated with levodopa may present shortly after the initiation of therapy and may be responsive to dose reduction of VYALEV or other concomitantly administered medications. |
| Metoclopramide | drug interactions | Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine) and isoniazid may reduce the effectiveness of foslevodopa. |
| Phenelzine | drug interactions | Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors The use of nonselective MAO inhibitors (e.g., phenelzine and tranylcypromine) with VYALEV is contraindicated [see Contraindications ( 4 ) ]. |
| Rasagiline | drug interactions | Selective MAO Inhibitors The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with VYALEV may be associated with orthostatic hypotension. |
| Risperidone | drug interactions | Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide, papaverine) and isoniazid may reduce the effectiveness of foslevodopa. |
| Selegiline | drug interactions | Selective MAO Inhibitors The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with VYALEV may be associated with orthostatic hypotension. |
| Tranylcypromine | drug interactions | Oxidase (MAO) Inhibitors Nonselective MAO Inhibitors The use of nonselective MAO inhibitors (e.g., phenelzine and tranylcypromine) with VYALEV is contraindicated [see Contraindications ( 4 ) ]. |
Source: FDA drug label (Vyalev), AbbVie Inc., effective March 19, 2026 (SPL set 28e806e4-951c-40a9-9f0c-d0929caf054c), via openFDA; the full label on DailyMed
What do FAERS reports show for foscarbidopa and foslevodopa?
The FDA Adverse Event Reporting System holds 7,378 reports that list foscarbidopa and foslevodopa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,155 are coded as a death and 4,012 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (4,251, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as foscarbidopa and foslevodopa?
1 other medicine is given the same way (subcutaneous) and in the same FDA class as foscarbidopa and foslevodopa or labeled mainly for the same use (parkinson's disease), the same class first. Parkinson's disease lists all 19 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Apomorphine | Parkinson's disease | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Foscarbidopa and foslevodopa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other