LOMAIRA (phentermine hydrochloride) · AVANTHI INC
Lomaira helps patients with weight reduction when used for a short period of a few weeks alongside exercise, behavioral changes, and a low-calorie diet. It treats exogenous obesity in individuals with a body mass index of 30 or higher. It is also used for patients with a body mass index of 27 or greater who have additional health risks such as diabetes, hyperlipidemia, or controlled hypertension.
How LOMAIRA Works
This drug works by acting as a sympathomimetic amine, which is a class of medications with similar activity to amphetamines. While often used to suppress appetite, it may also produce its effects through other central nervous system actions or metabolic changes.
Details
- Status
- Prescription
- First Approved
- 2016-09-12
- Routes
- ORAL
- Dosage Forms
- TABLET
LOMAIRA Approval History
What LOMAIRA Treats
1 indicationsLOMAIRA is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
LOMAIRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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.
LOMAIRA FDA Label Details
Indications & Usage
LOMAIRA™ tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in patients with an initial body mass index greater than or equal to 30 kg/m 2 , or greater than or equal to 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Below is a chart of body mass index (BMI) based on various heights and weights. BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s he...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.