Overview
Bacitracin is a combination of at least 9 bacitracins. 60-80% of commercially prepared bacitracin is bacitracin A. The bacillus that produces bacitracin was first isolated from a knee scrape in 1945 from the knee wound of a child named Margaret Tracy. Bacitracin was granted FDA approval on 29 July 1948.
Background
Bacitracin is a combination of at least 9 bacitracins. 60-80% of commercially prepared bacitracin is bacitracin A. The bacillus that produces bacitracin was first isolated from a knee scrape in 1945 from the knee wound of a child named Margaret Tracy. Bacitracin was granted FDA approval on 29 July 1948.
Indication
Bacitracin is indicated in topical formulations for acute and chronic localized skin infections. Occasionally, it is also used intramuscularly for infantile streptococcal pneumonia and empyema. Bacitracin is also formulated as an ointment with neomycin and polymyxin B for over the counter use. A bacitracin ointment formulated with neomycin and polymyxin B along with hydrocortisone is indicated for the treatment of corticosteroid responsive dermatoses with secondary infection.
Associated Conditions
- Acne
- Bacterial Infections of the Intestine
- Empyema
- Eye Infections
- Infection
- Inflammatory Reaction caused by Acne
- Ocular Inflammatory Disease
- Pneumonia
- Skin Ulcer
- Wound
- Wound Infections
- Corticosteroid-responsive dermatoses
- Infection in minor cuts, scrapes, or burns
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2019/04/26 | Phase 4 | Completed | Ascension South East Michigan | ||
2017/07/11 | Phase 1 | Completed | |||
2016/02/03 | Phase 4 | Terminated | |||
2012/08/17 | Phase 4 | Completed | |||
2011/05/09 | Phase 4 | Terminated | Susan Hassenbein | ||
2010/10/18 | Phase 2 | Completed | |||
2008/06/26 | Not Applicable | Withdrawn | |||
2005/08/22 | Phase 2 | Completed | |||
2001/08/31 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| MWI | 13985-608 | OPHTHALMIC | 400 [USP'U] in 1 g | 3/23/2015 | |
| Bausch & Lomb Incorporated | 24208-780 | OPHTHALMIC | 400 [USP'U] in 1 g | 6/30/2023 | |
| Trifecta Pharmaceuticals USA | 69396-061 | TOPICAL | 500 [USP'U] in 100 g | 5/12/2025 | |
| A-S Medication Solutions | 50090-3274 | OPHTHALMIC | 500 [USP'U] in 1 g | 1/31/2023 | |
| Padagis US LLC | 0574-4144 | OPHTHALMIC | 400 [USP'U] in 1 g | 11/9/2018 | |
| Phoenix Pharmaceutical, Inc. | 57319-343 | OPHTHALMIC | 400 [USP'U] in 1 g | 9/30/2010 | |
| RPK Pharmaceuticals, Inc. | 53002-9270 | OPHTHALMIC | 500 [USP'U] in 1 g | 11/12/2018 | |
| Butler Animal Health Supply | 11695-1406 | OPHTHALMIC | 400 [USP'U] in 1 g | 10/5/2010 | |
| Direct_Rx | 72189-017 | OPHTHALMIC | 500 [USP'U] in 1 g | 7/24/2019 | |
| MWI | 13985-607 | OPHTHALMIC | 400 [USP'U] in 1 g | 3/23/2015 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BANEOCIN POWDER | SIN00678P | POWDER | 250 iu/g | 5/3/1988 | |
| POLYBAMYCIN OINT. | SIN04413P | OINTMENT | 400 u/g | 5/3/1990 |
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 |
|---|---|---|---|---|---|
| BACITIN OINT 500UNITS/G | N/A | N/A | N/A | 9/25/1996 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||