NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
PAXIL CR (paroxetine hydrochloride) by Aurobindo Pharma is (mdd), panic disorder (pd), social anxiety disorder (sad), and premenstrual dysphoric disorder (pmdd) is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-ht). First approved in 1999.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PAXIL CR is an extended-release oral tablet formulation of paroxetine hydrochloride, a selective serotonin reuptake inhibitor (SSRI) approved for social anxiety disorder and anxiety disorders. It works by inhibiting neuronal reuptake of serotonin in the central nervous system, potentiating serotonergic activity. The mechanism is presumed but not definitively established.
$3MPart D
LOE ApproachingDeclining
Product is in late lifecycle with modest Part D spending of $3M across ~4K claims, signaling a mature, smaller commercial footprint requiring efficiency-focused team operations.
Mechanism of Action
(MDD), panic disorder (PD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD) is unknown, but is presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-HT).
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
Paxil CR Bioequivalence Study Brazil - Fed Administration
Started Oct 2009
60 enrolled
Depressive Disorder
Paxil CR Bioequivalence Study Brazil
Started Sep 2009
60 enrolled
Depressive Disorder
PAXIL CR Bioequivalence Study
Started Jul 2008
166 enrolled
Depressive Disorder
Clinical Evaluation of BRL29060A (Paroxetine Hydrochloride Hydrate) in Posttraumatic Stress Disorder (PTSD)
Started Jan 2008
5 enrolled
Post-Traumatic Stress DisorderStress Disorders, Post-Traumatic
Paroxetine Hydrochloride 40 mg Tablets Under Fasting Conditions
Started Oct 2002
50 enrolled
Healthy
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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.