ABACAVIR SULFATE
Pre-LaunchNDAORALTABLETPriority Review
Lifecycle
Pre-Launch
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
ABACAVIR SULFATE by Aurobindo Pharma is [see microbiology ()] . Approved for human immunodeficiency virus (hiv-1) infection, combination with other antiretroviral agents for the treatment of hiv-1 infection.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo 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
[see Microbiology ()] .
Clinical Trials (2)
Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers
Started Mar 2014
18 enrolled
Psoriasis
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
Started Feb 2004
54 enrolled
HIV Infections
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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.