NDAORALTABLETPriority Review
Approved
Mar 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Priority Review
MYSOLINE (primidone) by Bausch + Lomb. Approved for anti-epileptic agent [epc]. First approved in 1954.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYSOLINE (primidone) is an oral anti-epileptic agent approved in 1954 for seizure management. It is a small-molecule tablet indicated for epilepsy treatment across multiple seizure types. The drug works as a barbiturate derivative with anticonvulsant properties, though its precise mechanism of action is not fully characterized.
$14MPart D
LOE ApproachingStable
With LOE approaching and only $14M in annual spending, MYSOLINE represents a legacy product with a contracted team focused on maintenance and transition planning rather than growth initiatives.
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
Working on MYSOLINE offers limited career advancement given its LOE status and minimal commercial investment; roles are primarily defensive and compliance-focused. This product is best suited for professionals managing portfolio rationalization or those in early-career positions seeking foundational commercial experience in a lower-complexity environment.
Brand Manager (Legacy Products)
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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.