NDAORALTABLETPriority Review
Approved
May 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
Priority Review
AVANDIA (rosiglitazone maleate) by Dr. Reddy's Laboratories is 12. Approved for type 2 diabetes mellitus. First approved in 1999.
Drug data last refreshed 19h 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 mellitus. It works by activating peroxisome proliferator-activated receptor-gamma (PPARγ) to improve insulin sensitivity in adipose tissue, skeletal muscle, and liver. The drug reduces blood glucose by enhancing insulin-responsive gene transcription and inhibiting hepatic gluconeogenesis.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on lifecycle management and cost containment rather than growth initiatives.
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.