Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide: what the FDA reviewed for dog products
5 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Cats and dogs; Dogs and cats.
Products
- Animax® Cream (NADA/ANADA 200-330)
- Animax® Ointment (NADA/ANADA 140-847)
- DERMA-VET® Ointment (NADA/ANADA 140-810)
- Derma 4 Ointment (NADA/ANADA 140-879)
- Derma-Vet Cream (NADA/ANADA 200-245)
Derma 4 Ointment NADA 140-879, Original approval, August 02, 1989; sponsor Zoetis Inc.; species: Dogs and cats; foi_id 1366; FDA PDF
Indication
Acute and chronic otitis, interdigital cysts in dogs and cats, anal gland infections in dogs, inflammatory dry or exudative dermatitis complicated by bacterial or candidal infection, eczematous/contact/seborrheic dermatitis; adjunct for parasitic dermatitis
Dose regimen
not stated in summary, topical, not stated in summary
Route of Administration topical
Target-animal safety
| Finding | Quote |
|---|---|
| No new safety study; safety based on NAS/NRC review of Panalog and over 25 years of veterinary use | Likewise, the safety of this combination has been proven in over 25 years of continuous veterinary use. |
Effectiveness
No study: chemically identical to NAS/NRC-reviewed pioneer Panalog Ointment (NADA 12-258); bioequivalence waiver under 21 CFR 320.22 policy for topical products; result: Effectiveness accepted on the basis of the NAS/NRC review and over 25 years of continuous veterinary use
Since DERMA 4 Ointment is chemically identical to the NAS/NRC reviewed Panalog Ointment, the waiver applies to this product. The effectiveness of this combination has been proven in over 25 years of continuous veterinary use.
Extraction notes: Summary contains no dosage regimen beyond route (topical) and no PK or study data. Agency Conclusions list potential side effects (SAP/SGPT elevations, polydipsia/polyuria, vomiting, diarrhea, Cushings syndrome, deafness) without incidence data.
Derma-Vet Cream NADA 200-245, Original approval, June 07, 1999; sponsor Med-Pharmex, Inc.; species: Dogs and cats; foi_id 971; FDA PDF
Indication
Management of dermatologic disorders in dogs and cats characterized by inflammation and dry or exudative dermatitis, particularly with bacterial or candidal infection; also eczematous, contact and seborrheic dermatitis and adjunct for parasitic dermatitis
Dose regimen
thin film of cream, External application (topical), once daily to once a week (mild inflammation); as often as 2 to 3 times daily (severe conditions), Decrease frequency as improvement occurs; not for ophthalmic use
The recommended dosage is that the cream is to be applied as a thin f ilm. For mild inflammations, application may range from once daily to once a week. For severe conditions, the product may be applied as often as 2 to 3 times daily, if necessary. Frequency of treatment may be decreased as improvement occurs.
Effectiveness
No study: ANADA with formulation-based waiver of in vivo bioequivalence (not an effectiveness study); result: Waiver granted; same active and inactive ingredients in the same concentrations as the pioneer
Based on the formulation characteristics of the generic product, Med-Pharme x, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product Derma-Vet Cream. The generic product is administered as a topical ointment and contains the same active and inactive ingredients in the same concentrations as the pioneer product.
Extraction notes: Generic (ANADA); no new safety, effectiveness or PK data. PDF extraction artifacts ('managem ent', 'thin f ilm', 'Med-Pharme x') preserved verbatim in quotes.
DERMA-VET® Ointment NADA 140-810, Original approval, May 31, 1988; sponsor Med-Pharmex, Inc.; species: Cats and dogs; foi_id 1362; FDA PDF
Indication
Acute and chronic otitis of varied etiologies, interdigital cysts in cats and dogs, anal gland infections in dogs; management of inflammatory dry or exudative dermatitis complicated by bacterial or candidal infection, eczematous/contact/seborrheic dermatitis, adjunct for parasitic dermatitis
Dose regimen
amount per application not stated; composition per unit: nystatin 100,00 units [sic], neomycin sulfate 2.5 mg, thiostrepton 2,500 units, triamcinolone acetonide 1.0 mg, Topical, not stated in summary
Both products contain nystatin 100,00 units, neomycin sulfate 2.5 mg, thiostrepton, 2,500 units, and triamcinolone acetonide 1.0 mg.
Target-animal safety
| Finding | Quote |
|---|---|
| No new safety study; safety rests on NAS/NRC review of pioneer Panalog Ointment, with marketing status changed from OTC to Rx | The Council determined the product was safe and "probably effective" with labeling changes. The safety of the product was increased by changing its marketing status from over-the- counter (OTC) to prescription (Rx). |
Effectiveness
No study: generic NADA for pre-1962 pioneer Panalog Ointment (NADA 12-258) relying on NAS/NRC DESI review; in vivo bioequivalence waived under 21 CFR 320.22 for this topical product; result: Pioneer determined 'effective' by CVM after required label revisions; approval based on chemical equivalency
NAS/NRC determined Panalog Ointment to be "probably effective" and recommended labeling changes. Subsequently, the product was determined to be "effective" by the Center for Veterinary Medicine (CVM) when the application was supplemented by providing the required label revisions.
Extraction notes: Summary gives no dosage regimen (route Topical only); the dose_regimen quote is the composition statement, including the typo '100,00 units' preserved verbatim. No PK. Agency Conclusions list potential side effects requiring veterinary supervision (SAP and SGPT (ALT) enzyme elevations, polydypsia/polyuria, vomiting, diarrhea (occasionally bloody), Cushing's syndrome, deafness) without incidence data, so no adverse_reactions rows.
Animax® Cream NADA 200-330, Original approval, September 04, 2003; sponsor Fougera Pharmaceuticals, LLC; species: Dogs and cats; foi_id 1079; FDA PDF
Indication
Topical dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly associated with bacterial or candidal infections, in cats and dogs
Dose regimen
amount per application not stated (topical cream), Topical, once daily to once a week; 2 to 3 times daily for severe condition, Not for ophthalmic use
Recommended Dosage: Application ma y range from once daily to once a week. For severe condition, apply 2 to 3 times daily, if necessary.
Effectiveness
No study: ANADA with formulation-based waiver of in vivo bioequivalence (not an effectiveness study); result: Waiver granted August 25, 1998; same active and inactive ingredients as pioneer PANOLOG Cream (NADA 96-676)
Based upon the formulation characteristics of the generic product, Altana Inc. was granted a waiver on August 25, 1998, from the requirement for an in vivo bioequivalence study for ANIMAX Cream. The generic and pioneer products contain the same active and inactive ingredients in similar formulations.
Extraction notes: Generic (ANADA); no new safety, effectiveness or PK data. Composition per gram: nystatin 100,000 units, neomycin sulfate 2.5 mg, thiostrepton 2,500 units, triamcinolone acetonide 1.0 mg. PDF artifacts ('derm atologic', 'ma y') preserved verbatim.
Animax® Ointment NADA 140-847, Original approval, September 30, 1988; sponsor Fougera Pharmaceuticals, LLC; species: Cats and dogs; foi_id 1363; FDA PDF
Indication
Acute and chronic otitis of varied etiologies, interdigital cysts in cats and dogs, anal gland infections in dogs; management of inflammatory dry or exudative dermatitis complicated by bacterial or candidal infection, eczematous/contact/seborrheic dermatitis, adjunct for parasitic dermatitis
Dose regimen
Otitis: three to five drops instilled; anal gland/cyst: fill after draining; other dermatologic disorders: thin film applied sparingly, Topical, once daily to once a week (mild inflammation); as often as two or three times daily (severe conditions), Frequency may be decreased as improvement occurs
For mild inflammations, application may range from once daily to once a week; for severe conditions Animax Ointment may be applied as often as two or three times daily, if necessary. Frequency of treatment may be decreased as improvement occurs. Otitis: Clean ear canal of impacted cerumen. Inspect canal and remove any foreign bodies such as grass awns, ticks, etc. Instill three to five drops of Animax Ointment.
Target-animal safety
| Finding | Quote |
|---|---|
| No new safety study; safety rests on NAS/NRC review of pioneer Panalog Ointment, with marketing status changed from OTC to Rx | The Council determined the product was safe and "probably effective" with labeling changes. The safety of the product was increased by changing its marketing status from OTC to Rx. |
Effectiveness
No study: generic NADA for pre-1962 pioneer Panalog Ointment (NADA 12-258) relying on NAS/NRC DESI review; in vivo bioequivalence waived under 21 CFR 320.22; result: Pioneer determined 'effective' by CVM after required label revisions; approval based on chemical equivalency
NAS/NRC determined Panalog Ointment to be "probably effective" and recommended labeling changes. Subsequently, the product was determined to be "effective" by the Center for Veterinary Medicine (CVM) when the application was supplemented by providing the required label revisions.
Extraction notes: Batch plan flagged species 'unknown'; summary states the product is for use only on cats and dogs. Composition per General Information: nystatin 100,000 units, neomycin sulfate 2.5 mg, thiostrepton 2,500 units, triamcinolone acetonide 1.0 mg. No PK or incidence data; Agency Conclusions list potential side effects (SAP/SGPT elevations, polydypsia/polyuria, vomiting, diarrhea, Cushing's syndrome, deafness) without numbers.
Reproduce: foi_structured_search(query="Neomycin Sulfate, Nystatin, Thiostrepton, Triamcinolone Acetonide") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).