NDAINTRAVENOUSPOWDER
Approved
Jan 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ACETAMINOPHEN (acetaminophen) by Gland Pharma is 12. Approved for minor aches, pains due to: headache sore throat flu toothache the common cold temporarily reduces fever. First approved in 2021.
Drug data last refreshed 1w ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Acetaminophen is a widely used over-the-counter analgesic and antipyretic available as an intravenous powder formulation. It treats minor aches and pains including headache, sore throat, toothache, and flu symptoms while temporarily reducing fever. The drug's precise mechanism is not fully established but is thought to involve central nervous system actions.
Peak
Peak-stage product with established market presence; commercial teams likely focused on maintaining market share rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions. 12.2 Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human…
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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.