Miconazole Nitrate: what the FDA reviewed for dog products

2 Freedom of Information summaries from the FDA Center for Veterinary Medicine for products containing Miconazole Nitrate, as typed records: every value below is followed by the verbatim passage it was taken from. Species as stated by each summary: Dogs and cats.

Products

Miconosol NADA ANADA 200-196, Original approval, August 04, 1997; sponsor Med-Pharmex, Inc.; species: Dogs and cats; foi_id 1427; FDA PDF

Indication

Treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum and Trichophyton mentagrophytes.

Dose regimen

Light covering of 1% lotion/spray to affected areas, Topical (external application; lotion by gauze pad or cotton swab, spray from 2 to 4 inches), Once daily, 2 to 4 weeks; continue until organism eradicated; re-evaluate if no improvement within 2 weeks; difficult cases may require 6 weeks

Apply a light covering of MICONOSOL (miconazole nitrate) Lotion/Spray 1% to affected areas, once daily, for 2 to 4 weeks.

Effectiveness

Generic ANADA of Conofite (NADA 95-184); no effectiveness study. Waiver from in vivo bioequivalence studies granted on formulation characteristics.; result: Biowaiver granted; effectiveness study does not apply.

Med-Pharmex, Inc. applied for and received an approval of a waiver from in-vivo bioequivalency studies based upon the formulation characteristics of the generic product.

Extraction notes: Generic topical product with biowaiver; no PK, safety or effectiveness studies. Summary states no safety studies were required: 'Because this drug is a generic copy of a previously approved drug whose safety has been established, no safety studies have been required for this application.' Species not stated in a dedicated field; taken from the indication (dogs and cats). Batch plan flagged species as unknown.

Priconazole™ Lotion 1% and Spray 1% NADA ANADA 200-362, Original approval, November 14, 2005; sponsor First Priority, Inc.; species: Dogs and cats; foi_id 1116; FDA PDF

Indication

Topical treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

Dose regimen

A light covering to affected areas, Topical, Once daily, 2 to 4 weeks; product strength 1.15% miconazole nitrate (equivalent to 1% miconazole base)

Recommended Dosage: Apply a light covering to affected areas, once daily for 2 to 4 weeks.

Effectiveness

Generic ANADA of CONOFITE (NADA 095-184); no new studies. Waiver from in vivo bioequivalence study granted on formulation characteristics.; result: Biowaiver granted; new target animal safety and effectiveness data not required.

Based on the formulation characteristics of the generic product, First Priority, Inc. was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product PRICONAZOLE (miconazole nitrate) Lotion, 1% and Spray, 1%.

Extraction notes: Generic topical product with biowaiver; no PK, safety, effectiveness or adverse reaction data in the summary.

Reproduce: foi_structured_search(query="Miconazole Nitrate") and foi_summary_get(foi_id=...) in dog-geroscience-mcp; dataset foi-summaries-dog (config structured).