NDAORALTABLET, EXTENDED RELEASE
Approved
Mar 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
BIAXIN XL (clarithromycin) by AbbVie is 12. Approved for community-acquired bacterial pneumonia, mycobacterium avium complex infection, helicobacter pylori infection and 2 more indications. First approved in 2000.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIAXIN XL (clarithromycin) is an oral extended-release macrolide antibiotic that inhibits bacterial protein synthesis to treat respiratory, gastrointestinal, and systemic infections. It is indicated for community-acquired bacterial pneumonia, Mycobacterium avium complex infection, Helicobacter pylori infection, peptic ulcer disease, and complicated intra-abdominal infections. The drug achieves high tissue penetration, particularly in lung and tonsil tissue, enabling effective treatment of localized infections.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating contracting brand team and shift toward generic transition management.
Mechanism of Action
12.1 Mechanism of Action Clarithromycin is a macrolide antimicrobial drug [see ] . 12.3 Pharmacokinetics Absorption The absolute bioavailability of 250 mg clarithromycin tablets was approximately 50%. For a single 500 mg dose of clarithromycin, food slightly delays the onset of clarithromycin…
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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.