MedPath

Colistimethate

Generic Name
Colistimethate
Brand Names
Colobreathe, Coly Mycin M, Xylistin
Drug Type
Small Molecule
Chemical Formula
C58H105N16O28S5
CAS Number
12705-41-8
Unique Ingredient Identifier
DL2R53P963

Overview

Colistimethate is an antibiotic that has been shown to have bactericidal activity against aerobic gram-negative microorganisms. Colistimethate is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa.

Indication

For the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli, particularly Pseudomonas aeruginosa.

Associated Conditions

  • Bacterial Infections

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/03/25
Phase 4
Active, not recruiting
2025/02/19
Not Applicable
Recruiting
2024/11/25
N/A
Not yet recruiting
2024/07/05
Phase 2
Not yet recruiting
2024/01/10
Phase 3
Recruiting
2022/10/19
Phase 4
Completed
2018/01/12
Phase 4
Completed
National Cancer Institute, Egypt
2016/11/17
Phase 4
Completed
Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
2015/06/26
N/A
Completed
2015/05/22
Phase 3
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Fresenius Kabi USA, LLC
63323-393
INTRAMUSCULAR, INTRAVENOUS
150 mg in 2 mL
1/23/2020
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-193
INTRAMUSCULAR, INTRAVENOUS
150 mg in 4 mL
7/5/2022
XGen Pharmaceuticals DJB, Inc.
39822-0615
INTRAMUSCULAR, INTRAVENOUS
150 mg in 2 mL
12/2/2022
Xellia Pharmaceuticals USA LLC
70594-023
INTRAMUSCULAR, INTRAVENOUS
150 mg in 1 1
6/25/2020
Nexus Pharmaceuticals Inc
14789-201
INTRAVENOUS, INTRAMUSCULAR
150 mg in 1 1
9/28/2021
Xellia Pharmaceuticals USA LLC
70594-023
INTRAVENOUS, INTRAMUSCULAR
150 mg in 1 1
3/2/2022
Par Pharmaceutical, Inc.
42023-107
INTRAMUSCULAR, INTRAVENOUS
150 mg in 2 mL
12/10/2021

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
COLISTIMETHATE FOR INJECTION USP
marcan pharmaceuticals inc
02546639
Powder For Solution - Intramuscular ,  Intravenous
150 MG / VIAL
6/10/2024

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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