AZITHROMYCIN

Post-LOE

azithromycin dihydrate

Pfizer

ANDAORALTABLET

Approved

Sep 2018

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

AZITHROMYCIN (azithromycin dihydrate) by Pfizer is drug. Approved for disseminated mac disease in persons with advanced hiv infection, disseminated mac infections in persons with advanced hiv infection. First approved in 2018.

Drug data last refreshed 19h ago

Mechanism of Action

drug. [see ]

Indications (2)

disseminated MAC disease in persons with advanced HIV infection disseminated MAC infections in persons with advanced HIV infection

Clinical Trials (20)

NCT06605118Phase 3Recruiting

Azithromycin Prophylaxis for PRElabor CEsarean DElivery Trial

Started Nov 2024

8,000 enrolled

Obstetrical ComplicationsLabor and Delivery ComplicationCesarean Delivery

NCT06010719Phase 4Recruiting

Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition

Started Oct 2024

3,000 enrolled

Malnutrition, ChildSevere Acute Malnutrition

NCT06273891Phase 3Recruiting

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

Started Mar 2024

140 enrolled

Premature Rupture of Membrane

NCT05772013Phase 4Recruiting

Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations

Started Mar 2024

1,311 enrolled

Chronic Obstructive Pulmonary Disease

NCT06543290Phase 1Recruiting

Azithromycin Before Induction

Started Aug 2023

400 enrolled

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.