Vancocin Hydrochloride

(Vancomycin capsule)

HHikma Pharmaceuticals LLC

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Timeline

Expected Milestones

Q4 2030

Phase 3Recruiting

Colitis

NCT07328971

Clinical

Trials by Indication[1]

Colitis1 trial

Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial

Recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT07328971·500 enrolled

Regulatory

FDA Approval Timeline[3]

Apr 15, 1986

VANCOCIN HYDROCHLORIDE

NDA NDA050606

Mar 1, 1999

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

NDA NDA050671

Jan 26, 2018

FIRVANQ KIT

NDA NDA208910

Jul 10, 2018

VANCOMYCIN HYDROCHLORIDE

NDA NDA209481

Feb 15, 2019

TYZAVAN

NDA NDA211962

Aug 26, 2021

VANCOMYCIN

NDA NDA213895

Jan 20, 2023

VANCOMYCIN HYDROCHLORIDE

NDA NDA210274

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Vancomycin capsule. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vancomycin capsule compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA210274). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Hikma Pharmaceuticals LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Company: HHikma Pharmaceuticals LLC