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 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Abacavir sulfate is a nucleoside reverse transcriptase inhibitor (NRTI) oral tablet used in combination with other antiretroviral agents to treat HIV-1 infection. It works by inhibiting HIV reverse transcriptase, preventing viral replication in infected cells. The drug is rapidly absorbed with ~83% bioavailability and distributes into extravascular spaces including cerebrospinal fluid.
Pre-Launch
Pre-launch stage indicates small commercial teams focused on regulatory clearance and preparation for market entry; limited current market penetration.
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.