NDAORALCAPSULE
Approved
Oct 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
SERTRALINE HYDROCHLORIDE (sertraline hydrochloride) by Almatica Pharma is 12. First approved in 2021.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) that potentiates serotonergic activity in the central nervous system by blocking neuronal reuptake of serotonin (5-HT). It is indicated for depression, anxiety disorders, OCD, panic disorder, PTSD, and premenstrual dysphoric disorder. The drug demonstrates high selectivity for serotonin reuptake with minimal effects on norepinephrine and dopamine systems.
Peak
Peak lifecycle stage indicates mature commercial maturity with established market penetration; organizational structure likely fully built out with stable field presence.
Mechanism of Action
12.1 Mechanism of Action Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT). 12.2 Pharmacodynamics Studies at clinically relevant doses have demonstrated that sertraline blocks the uptake of serotonin into human…
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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.