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Label indication ZITHROMAX (azithromycin) is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. FDA label
Azithromycin · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Azithromycin Tablets 600 mg |
| 2 | ACTIVE_COMPARATOR | Zithromax® Tablets 600 mg |
| Name | Type | Description |
|---|---|---|
| Azithromycin Tablets 600 mg | DRUG | 600mg, single dose fed |
| Zithromax® Tablets 600 mg | DRUG | 600mg, single dose fed |
Inclusion Criteria: * 1\. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 14 days prior to the start of the study and on the ...
Azithromycin is a small molecule drug. Viatris Inc. is developing Azithromycin Tablets 600 mg, which has been studied in Phase 1 clinical trials. The specific therapeutic indication for this development program is undisclosed.
Viatris Inc. (ticker: VTRS) is the developer of Azithromycin Tablets 600 mg. The company is responsible for the clinical development of this product.
Azithromycin Tablets 600 mg is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials listed for this specific product.
Azithromycin Tablets 600 mg has been evaluated in two completed Phase 1 trials: NCT00650273 (fasting study) and NCT00649935 (fed study). Both trials compared the tablets to Zithromax® Tablets 600 mg in healthy volunteers.