100 mg clindamycin /800 mg ketoconazole vaginal ovule

Phase 3

MERCK (MRK)

Phase 3

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Vaginosis, Bacterial

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Drug Information

Target Indication

Vaginosis, Bacterial

Clinical Trial

NCT01293643

Last updated: 12/23/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMAPending

Ketoconazole AID-SCFM

Treatment of Cushings syndrome

View on EMA

EMA11/18/2014

Ketoconazole Esteve (previously Ketoconazole HRA)

Ketoconazole Esteve is indicated for the treatment of endogenous Cushing’s syndrome in adults and adolescents above the age of 12 years.

Accelerated

View on EMA

Drug Science

Mechanism of action & safety profile

Developer

MRK

MERCK

Pharmaceutical Preparations•North America•NASDAQ

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