NDAORALCAPSULE, EXTENDED RELEASE
Approved
Apr 1979
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
PHENDIMETRAZINE TARTRATE (phendimetrazine tartrate) by Novartis is clinical pharmacology phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Approved for the management of exogenous obesity, equal to 30 kg/m, greater than and 2 more indications. First approved in 1979.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Phendimetrazine tartrate is an oral sympathomimetic amine indicated for management of exogenous obesity in patients with BMI ≥30 kg/m² or ≥27 kg/m² with comorbidities like hypertension. It works as a central nervous system stimulant that suppresses appetite and elevates blood pressure, with effects similar to amphetamines. The extended-release capsule formulation (105 mg) approximates three 35 mg immediate-release doses taken at 4-hour intervals.
LOE Approaching
Product is in late-lifecycle stage with approaching loss of exclusivity, signaling transitional team focus toward cost containment and market share defense.
Mechanism of Action
CLINICAL PHARMACOLOGY Phendimetrazine tartrate is a phenylalkylamine sympathomimetic amine with pharmacological activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis…
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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.