NDAORALTABLET, DELAYED RELEASE
Approved
Jun 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
2/8 — Basic
Drug data last refreshed 8h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DYNABAC (dirithromycin) is an oral macrolide antibiotic approved in 1995 for treating bacterial infections. It is a semi-synthetic macrolide that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. The delayed-release tablet formulation is designed to improve tolerability and compliance in patients with respiratory and skin infections.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30/100), signaling smaller commercial teams focused on maintenance rather than growth.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Semi-replicate Crossover Bioequivalence Study of Dirithromycin of (Abdi İbrahim İlaç San. Ve Tic. A. Ş., Turkey) in Healthy Subjects Under Fasting Conditions
Started Dec 2014
48 enrolled
Healthy
Semi-replicate Crossover Bioequivalence Study of Dirithromycin in Healthy Subjects Under Fed Conditions
Started Sep 2014
48 enrolled
Healthy
Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fasting Condition
Started Jun 2014
12 enrolled
Healthy
Bioequivalence Pilot Study of Dirithromycin of (Abdi İbrahim İlaç San.Ve.Tic.A.Ş,Turkey) in Healthy Subjects Under Fed Condition
Started Jun 2014
12 enrolled
Healthy
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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.