NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
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 21h ago · AI intelligence enriched 1w ago
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 in 1999. It treats major depressive disorder (MDD), panic disorder, social anxiety disorder, and premenstrual dysphoric disorder by inhibiting neuronal reuptake of serotonin to potentiate serotonergic activity in the central nervous system.
$3MPart D
LOE ApproachingWith lifecycle status approaching loss of exclusivity and minimal recent Part D spending, this product faces declining commercial importance and likely diminishing team resources.
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 (11)
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
Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg
Started Dec 2006
36 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.