NDAORALTABLETPriority Review
Approved
Mar 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYSOLINE (primidone) is an oral anti-epileptic agent approved in 1954 for seizure management. It works through mechanisms not fully understood but raises seizure thresholds and alters seizure patterns; it is metabolized to two active compounds—phenobarbital and phenylethylmalonamide (PEMA)—both of which contribute to its anticonvulsant effect. As a first-generation barbiturate-derivative antiepileptic, it occupies a legacy position in the treatment landscape, now facing substantial competition from newer agents with improved tolerability profiles.
$0.0BPart D
Mechanism of Action
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions
Started Aug 2006
24 enrolled
Healthy
Career Relevance
MYSOLINE's declining market position creates limited career opportunities; current roles are primarily in mature brand management, field sales support for legacy prescribers, and regulatory compliance. Skills most valuable are deep knowledge of first-generation antiepileptics, seizure disorder management, and physician relationship maintenance in niche prescriber segments. Zero linked open positions indicates minimal active hiring for this product, reflecting its mature and shrinking market footprint.
Company
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.