ABACAVIR SULFATE
Pre-LaunchNDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
ABACAVIR SULFATE by Aurobindo Pharma is 12. Approved for human immunodeficiency virus (hiv-1) infection, combination with other antiretroviral agents for the treatment of hiv-1 infection.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Abacavir sulfate is a nucleoside reverse transcriptase inhibitor (NRTI) oral antiretroviral agent approved for HIV-1 infection treatment. It is rapidly absorbed, extensively distributed, and undergoes hepatic metabolism via alcohol dehydrogenase and glucuronyl transferase. The drug is used to manage HIV infection and related conditions including lipodystrophy and wasting disease.
Pre-Launch
Pre-launch stage suggests active commercial planning and team buildout; limited current staffing but growth phase preparation underway.
Mechanism of Action
12.1 Mechanism of Action Abacavir is an antiretroviral agent [see ]. 12.3 Pharmacokinetics Pharmacokinetics in Adults The pharmacokinetic properties of abacavir were independent of dose over the range of 300 to 1,200 mg per day. Absorption Following oral administration, abacavir is rapidly absorbed…
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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.