NDAORALTABLETPriority Review
Approved
Jul 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
MALARONE PEDIATRIC (atovaquone and proguanil hydrochloride) by GSK. Approved for antimalarial [epc]. First approved in 2000.
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Malarone Pediatric is an oral fixed-dose combination of atovaquone and proguanil hydrochloride indicated for malaria prevention and treatment in pediatric patients. The drug works through dual antimalarial mechanisms, inhibiting parasite mitochondrial function and folate metabolism. It is formulated as tablets optimized for pediatric dosing.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential downsizing or reallocation of commercial resources to next-generation assets.
Mechanism of Action
Pharmacologic Class:
Antimalarial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Zero linked job postings and approaching LOE status indicate minimal career opportunity on Malarone Pediatric; roles on this product are primarily legacy positions focused on managed decline rather than growth. Professionals should consider transition planning to GSK's emerging infectious disease or tropical medicine portfolios.
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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.