NDAINJECTIONINJECTABLE
Approved
Oct 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
LOXITANE IM (loxapine hydrochloride) by Teva is clinical pharmacology pharmacodynamics: pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. Approved for schizophrenia. First approved in 1979.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOXITANE IM is a first-generation antipsychotic containing loxapine hydrochloride delivered via intramuscular injection for rapid symptom control in schizophrenia. The exact mechanism remains unclear, but the drug modulates subcortical inhibitory areas to produce sedation, calming effects, and suppression of aggressive behavior within 20–30 minutes of administration. It is extensively metabolized and primarily excreted within 24 hours.
LOE Approaching
LOXITANE IM faces imminent loss of exclusivity in a mature, competitive schizophrenia market; brand team size is likely minimal and focused on managed care retention rather than growth.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics: Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such…
Indications (1)
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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.