NDAINJECTIONINJECTABLEPriority Review
Approved
Oct 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
Priority Review
PENTAM (pentamidine isethionate) by Fresenius Kabi is clinical pharmacology pentamidine isethionate, an aromatic diamidine, is known to have activity against pneumocystis carinii . First approved in 1984.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PENTAM (pentamidine isethionate) is an aromatic diamidine antiprotozoal agent approved in 1984 for treatment of Pneumocystis carinii pneumonia (PCP), primarily in immunocompromised patients such as those with AIDS. The drug interferes with protozoal nuclear metabolism by inhibiting DNA, RNA, phospholipid, and protein synthesis. It is administered via intravenous infusion or intramuscular injection.
LOE Approaching
As a 40-year-old product approaching loss of exclusivity with moderate competitive pressure (30/100), the brand team is likely focused on lifecycle maintenance and cost management rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Pentamidine isethionate, an aromatic diamidine, is known to have activity against Pneumocystis carinii . The mode of action of pentamidine is not fully understood. In vitro studies indicate that the drug interferes with protozoal nuclear metabolism by inhibition of DNA, RNA,…
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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.