Mupirocin: what the FDA reviewed for dog products
4 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Mupirocin, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs.
Products
- Bactoderm® Ointment (NADA/ANADA 140-839)
- Mupirocin Ointment 2% (NADA/ANADA 200-524)
- Mupirocin Ointment USP, 2% (NADA/ANADA 200-457)
- Muricin™ (NADA/ANADA 200-418)
Mupirocin Ointment 2% NADA 200-524, Original approval, June 24, 2013; sponsor Putney, Inc.; species: Dogs; foi_id 1216; FDA PDF
Indication
Topical treatment of canine bacterial skin infections, including superficial pyoderma, caused by susceptible Staphylococcus aureus and Staphylococcus intermedius
Dose regimen
2% ointment; sufficient amount to completely cover the infected area, Topical, twice a day, Cleanse lesion prior to treatment; maximum duration of treatment should not exceed 30 days
Prior to treatment, the lesion should be cleansed. Mupirocin Ointment 2% should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.
Effectiveness
No study: ANADA with formulation-based waiver of bioequivalence (not an effectiveness study); result: Waiver granted; CVM did not require effectiveness or target animal safety studies
Based on the formulation characteristics of the generic product, Putney, Inc. was granted a waiver from the requirement to demonstrate bioequivalence for the generic product Mupirocin (mupirocin) Ointment 2%.
Extraction notes: Generic (ANADA). Summary states 'CVM did not require effectiveness studies for this approval.' and 'CVM did not require target animal safety studies for this approval.' No PK data.
Muricin™ NADA 200-418, Original approval, March 08, 2007; sponsor Fougera Pharmaceuticals, LLC; species: Dogs; foi_id 1149; FDA PDF
Indication
Topical treatment of canine bacterial skin infections, including superficial pyoderma, caused by susceptible Staphylococcus aureus and Staphylococcus intermedius
Dose regimen
2% ointment; sufficient amount to completely cover the infected area, Topical, twice a day, Clean lesion prior to treatment; maximum duration of treatment should not exceed 30 days
MURICIN Ointment 2% should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.
Effectiveness
No study: ANADA with formulation-based waiver of in vivo bioequivalence (not an effectiveness study); result: Waiver granted; generic considered equivalent to pioneer BACTODERM Ointment 2% (NADA 140-839)
Based on the formulation characteristics of the generic product, Altana Inc. was granted a waiver f rom the requirement for an in vivo bioequivalence study for the generic product MURICIN (mupirocin) Ointment 2%.
Extraction notes: Generic (ANADA); no new target animal safety, effectiveness or PK data. The effectiveness entry records only the bioequivalence waiver. 'waiver f rom' is a PDF extraction artifact preserved verbatim.
Mupirocin Ointment USP, 2% NADA 200-457, Original approval, November 29, 2010; sponsor Taro Pharmaceuticals U.S.A., Inc.; species: Dogs; foi_id 1177; FDA PDF
Indication
Treatment of bacterial skin infections, including superficial pyoderma, caused by susceptible Staphylococcus aureus and Staphylococcus intermedius
Dose regimen
sufficient amount of ointment to completely cover the infected area, Topical, twice a day, Maximum duration of treatment should not exceed 30 days
Mupirocin ointment should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the infected area. Maximum duration of treatment should not exceed 30 days.
Effectiveness
No study: ANADA with formulation-based waiver of in vivo bioequivalence (not an effectiveness study); result: Waiver granted; same active ingredient, concentration and dosage form as RLNAD BACTODERM (NADA 140-839)
Based on the formulation characteristics of the generic product, Taro Pharmaceuticals U.S.A., Inc., was granted a waiver from the requirement for an in vivo bioequivalence study for the generic product Mupirocin Ointment 2%.
Extraction notes: Generic (ANADA); no new target animal safety, effectiveness or PK data. Product strength 2% (20 mg/g) per General Information.
Bactoderm® Ointment NADA 140-839, Original approval, September 28, 1988; sponsor Zoetis Inc.; species: Dogs; foi_id 2479; FDA PDF
Indication
Topical treatment of canine bacterial skin infections, including superficial pyoderma, caused by susceptible Staphylococcus aureus and Staphylococcus intermedius
Dose regimen
sufficient amount of ointment to completely cover the affected area, Topical, twice a day, Cleanse lesion prior to treatment; maximum duration of treatment should not exceed 30 days
BACTODERM Ointment should be applied to the affected area twice a day. Apply a sufficient amount of ointment to completely cover the affected area. The maximum duration of treatment should not exceed 30 days.
Target-animal safety
dose multiples 2% (1X), 6% (3X), 10% (5X); duration twice a day for six consecutive weeks (necropsy day 43/44); animals 10 male and 10 female.
Ten male and 10 female adult Beagle dogs were used. Two days prior to treatment the dogs were divided into five groups, each consisting of two males and two females. This study was an open evaluation of mupirocin utilizing three dosage levels of the test drug (2, 6, and 10%), a placebo group and a control group (no medication). The ointment was administered topically to abraded skin lesions twice a day for six weeks.
| Finding | Quote |
|---|---|
| No clinically significant effects on body temperature, heart rate, respiratory rate, body weight or food consumption | No values were obtained which were considered to be clinically significant in regard to body temperature, heart rate, respiratory rate, body weight and food consumption. |
| All test concentrations produced erythema (pink to deep red); vehicle and 2% mupirocin produced only mild erythema | In regard to the dermal scoring, all levels of test material produced erythema ranging from pink to deep red. The vehicle control and 2% mupirocin produced mild erythema. |
| Initial edema in all test groups; only scattered edema after day 26 except one dog in the 6% group | Some edema was observed in all of the test groups initially. With the exception of one dog in the 6% mupirocin group, there was only a scattered incidence of edema after day 26. |
| No consistent hematology, clinical chemistry or urinalysis changes | Hematology, blood chemistries and urinalysis did not show any consistent pattern of variations. |
| Histopathology: no meaningful differences at application site between groups; all reactions minimal to mild | Histopathological examination did not show any meaningful differences in type or severity of reaction at the test article application site between the five groups. All reactions at the application sites were minimal to mild. |
Effectiveness
Pivotal blind, randomized, parallel-group, multi-center field study (17 investigators, 11 states) of BACTODERM vs vehicle ointment applied twice daily in dogs with bacterial pustular dermatitis; analysis of evaluable cases with S. aureus isolated; n = 57 evaluable (28 BACTODERM, 29 vehicle); primary endpoint: Animal success = clinical cure or improvement plus elimination of the bacterial isolate; result: Animal success 61% (17/28) with BACTODERM vs 45% (13/29) with vehicle ointment
Of the 57 evaluable pustular dermatitis cases in which S. aureus was isolated, 28 were treated with BACTODERM Ointment while 29 were treated with the vehicle ointment. When the clinical response was judged to be a cure or improvement and the bacterial isolate was eliminated, the case was classified as an animal success. A 61% (17/28) animal success rate was observed following treatment with BACTODERM Ointment. The vehicle ointment resulted in an animal success rate of 45% (13/29).
Extraction notes: No adverse-reaction table in the summary (field study reports only success rates); no PK data (topical product). TAS dose levels are ointment concentrations 2, 6 and 10% in the 6-week abraded-skin study; the 1X/3X/5X labels are extractor arithmetic relative to the 2% product. Pivotal experimentally induced S. intermedius model (23 dogs: 9 BACTODERM, 9 vehicle, 5 untreated): 78% of BACTODERM dogs vs 33% vehicle negative for pathogen by last day of treatment. Corroborative lab-animal toxicology (rat, mouse, rabbit, squirrel monkey), a 3-month IV repeat-dose Beagle study (5/10/20 mg/kg) and an IV cardiovascular study in 3 anesthetized Beagles are summarized but not extracted here.
Reproduce: foi_structured_search(query="Mupirocin") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).