NDAORALCAPSULE
Approved
Feb 2006
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20
Data completeness
4/8 — Partial
NAPROXEN SODIUM (naproxen sodium) by Humanwell Pharmaceutical is analgesic, anti-inflammatory, and antipyretic properties. First approved in 2006.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Naproxen sodium is an oral NSAID capsule approved in 2006 that provides analgesic, anti-inflammatory, and antipyretic effects through COX-1 and COX-2 inhibition. It reduces prostaglandin synthesis in peripheral tissues to decrease pain and inflammation. The drug is indicated for patients requiring rapid, short-term pain relief.
Post-LOEPost-LOE
Post-LOE status with moderate competitive pressure (35) indicates a mature, stable franchise with focus on efficiency and cost management rather than growth initiatives.
Mechanism of Action
analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen sodium is a potent inhibitor of prostaglandin synthesis in vitro . Naproxen…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Multiple-Dose Safety Study of Fixed Combination of Acetaminophen/Naproxen Sodium in Adolescents With Orthodontic Pain
Started Jan 2024
0Orthodontic Pain
A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain
Started Sep 2023
24 enrolled
Orthodontic Pain
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
Started Sep 2023
143 enrolled
Pain
A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain
Started May 2023
447 enrolled
Pain
A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo
Started Sep 2022
541 enrolled
Postoperative Dental Pain
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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.