BRISDELLE
Details
- Status
- Prescription
- First Approved
- 2013-06-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
BRISDELLE Approval History
What BRISDELLE Treats
2 indicationsBRISDELLE is approved for 2 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
- Menopause
BRISDELLE Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Selective serotonin reuptake inhibitors (SSRIs) increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term trials for the treatment of major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, closely monitor BRISDELLE-treated patients closely for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . BRISDELLE is not approved for use in any psychiatric cond...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Selective serotonin reuptake inhibitors (SSRIs) increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term trials for the treatment of major depressive disorder and other psychiatric disorders. Because BRISDELLE is an SSRI, closely monitor BRISDELLE-treated patients closely for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . BRISDELLE is not approved for use in any psychiatric condition or in pediatric and young adult patients [see Indications and Usage ( 1 ) and Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), increased the risk of suicidal thoughts and behavior in pediatric and young adult patients with major depressive disorder and other psychiatric disorder. Because BRISDELLE is an SSRI, closely monitor patients for clinical worsening and for emergence of suicidal thoughts and behaviors. BRISDELLE is not approved for use in pediatric and young adult patients ( 5.1 ).
Drugs Similar to BRISDELLE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BRISDELLE FDA Label Details
ProIndications & Usage
FDA Label (PDF)BRISDELLE is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Limitations of Use: BRISDELLE is not indicated for the treatment of any psychiatric condition. BRISDELLE has a lower recommended paroxetine dosage than that used to treat major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder. The safety and effectiveness of the lower BRISDELLE dosage has not been established for any psychiatric condition. Patients who require paroxetine fo...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Selective serotonin reuptake inhibitors (SSRIs) increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term trials for the treatment of major depressive disorder and other psychiatric disorders. Because BRISDELLE i...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.