NDAINJECTIONINJECTABLEPriority Review
Approved
Jan 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
LEVO-DROMORAN (levorphanol tartrate) by Bausch + Lomb is clinical pharmacology mechanism of action levorphanol is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Approved for pain severe enough to require an opioid analgesic, for which alternative treatments are inadequate. First approved in 1953.
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVO-DROMORAN (levorphanol tartrate) is a full mu-opioid receptor agonist injectable analgesic approved in 1953 for severe pain when alternative treatments are inadequate. It works by binding to opioid receptors in the central nervous system to produce analgesia without a ceiling effect. The drug is administered via injection and produces pain relief through direct CNS action, though the precise mechanism remains incompletely understood.
LOE Approaching
Product is approaching loss of exclusivity with minimal commercial data publicly available, suggesting a small, legacy brand team with limited growth opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Levorphanol is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of levorphanol is analgesia. Like all full opioid agonists, there…
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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.