PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE (phentermine hydrochloride) · Teva
Phentermine hydrochloride helps patients with weight reduction when used for a short period of time alongside exercise, behavioral changes, and a low-calorie diet. It treats exogenous obesity in individuals with a body mass index (BMI) of 30 or higher, or those with a BMI of 27 or higher who also have risk factors like diabetes, high blood pressure, or high cholesterol. Because its effectiveness is limited to a few weeks, it is used as a temporary addition to a broader weight management plan.
How PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE Works
As a sympathomimetic amine, this medication works by mimicking the activity of amphetamines to support weight loss. While it is classified as an anorectic, its effects may involve various central nervous system actions or metabolic changes beyond simple appetite suppression.
Details
- Status
- Prescription
- First Approved
- 2024-06-25
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE Approval History
What PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE Treats
4 indicationsPHENTERMINE HYDROCHLORIDE AND TOPIRAMATE is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity
- Hypertension
- Diabetes
- Hyperlipidemia
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE Competitive Set
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Indication competitors
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What's emerging in PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE treats. First-in-class if their pivotal trials read out positive.
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Teva's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE FDA Label Details
Indications & Usage
Phentermine and topiramate extended-release capsules are indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adult patients with obesity Adults with overweight in the presence of at least one weight-related comorbid condition Limitations of Use • The effect of phentermine and topiramate extended-release capsules on cardiovascular morbidity and mortality has not been established. • The safety and effectiveness of phentermine and topiramate extended-release capsules in combination with other...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.