Active substance
Polymyxin b
- US FDA 10
- WHO EML 1
- Safety 7
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 10 Jan 2008 |
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | XELLIA PHARMS APS | Prescription | 15 Jan 2014 |
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | EUGIA PHARMA | Prescription | 4 Apr 2016 |
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | GLAND | Prescription | 14 Apr 2016 |
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | HIKMA PHARMS | Discontinued | 29 Jun 1964 |
| POLY-RX | 100,000,000 UNITS/BOT | powder · for rx compounding | X GEN PHARMS | Discontinued | 5 Jan 1972 |
| AEROSPORIN | EQ 500,000 UNITS BASE/VIAL | injectable · injection | GLAXOSMITHKLINE | Discontinued | 13 Nov 1980 |
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | PHARMOBEDIENT | Discontinued | 30 Sep 1994 |
| POLYMYXIN B SULFATE | EQ 500,000 UNITS BASE/VIAL | injectable · injection | RISING | Discontinued | 29 Jun 2011 |
| POLYMYXIN B SULFATE | 100,000,000 UNITS/BOT | powder · for rx compounding | PADDOCK LLC | Discontinued |
WHO WHO Model List of Essential Medicines (2025)
- 6.2.3. Reserve group antibiotics · complementary
Carbapenem-resistant Pseudomonas aeruginosa; Carbapenem resistant Acinetobacter baumannii; Other carbapenem resistant Enterobacterales; Carbapenem resistant Klebsiella pneumoniae; Carbapenem resistant Escherichia coli
Parenteral > General injections > IV: 500000 IU in vial powder for injection (equivalent to 50 mg polymyxin B base)
Safety signals and safety-related labeling changes
- US FDA 8 Aug 2025 CORTISPORIN — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 8 Aug 2025 CORTISPORIN — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 8 Aug 2025 CORTISPORIN — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 4 Aug 2025 POLYTRIM — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 14 May 2021 MAXITROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 14 May 2021 MAXITROL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 May 2020 NEOSPORIN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations
Combinations containing Polymyxin b
- Bacitracin + polymyxin b
- Bacitracin zinc + polymyxin b
- Neomycin + polymyxin b
- Polymyxin b + trimethoprim
- Bacitracin + neomycin + polymyxin b
- Dexamethasone + neomycin + polymyxin b
- Gramicidin + neomycin + polymyxin b
- Hydrocortisone + neomycin + polymyxin b
- Hydrocortisone + oxytetracycline + polymyxin b
- Neomycin + nystatin + polymyxin b
- Neomycin + polymyxin b + prednisolone
- Bacitracin + neomycin + polymyxin b + zinc oxide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.