NDAORALTABLETPriority Review
Approved
May 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
Priority Review
AVANDIA (rosiglitazone maleate) by Dr. Reddy's Laboratories is 12. First approved in 1999.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AVANDIA (rosiglitazone maleate) is an oral thiazolidinedione antidiabetic agent approved in 1999 for type 2 diabetes. It improves glycemic control by activating PPARγ nuclear receptors in adipose tissue, muscle, and liver, thereby enhancing insulin sensitivity and reducing hepatic gluconeogenesis. The drug reduces blood glucose and hyperinsulinemia without inducing hypoglycemia in insulin-resistant patients.
LOE Approaching
Product is in LOE-approaching phase with moderate competitive pressure (30/100), indicating declining market opportunities and likely team contraction or consolidation.
Mechanism of Action
12.1 Mechanism of Action Rosiglitazone, a member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ). In humans,…
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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.