Approval Date: July 17, 1989
I. GENERAL INFORMATION:
HESS & CLARK, INC.
7th & Orange Sts.
Ashland, OH 44805
nitrofurazone soluble powder
NFZ Wound powder
II. INDICATIONS FOR USE
For the prevention or treatment of surface bacterial infections of wounds, burns, skin ulcers and abscesses after incision. For use only on dogs, cats and horses (not for food use).
Water soluble antibacterial powder containing 0.2% nitrofurazone.
ROUTE OF ADMINISTRATION
As needed. Apply several times daily to the lesion or affected area.
IV. & V. EFFECTIVENESS AND SAFETY
Nitrofurazone Ointment (Furacin Soluble Powder Veterinary, NADA 6-475) was the subject of a review by the National Academy of Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group, the results of which were published in the Federal Register of January 19, 1979 (44 FR 4014). NAS/NRC concluded, and FDA concurred, that the product was "effective" for the prevention or treatment of surface bacterial infections of wounds, burns, skin ulcers, and abscesses after incision. Due to concern for the safety of residues from food producing animals, FDA concluded that use of this and other NAS/NRC- reviewed nitrofurazone topical products must be limited to dogs, cats, and horses (not intended for food use). The Federal Register publication dated January 19 1979, on Nitrofurazone Topical Preparations for use in non-food animals, states that applications providing for the effective conditions of use identified in that notice need not include data required by 21 CFR 514.111 to establish the effectiveness of the drug for these uses.
Under Center for Veterinary Medicine policy, the principles of 21 CFR 320.22 providing for a waive of the requirement for submission of evidence of in vivo bioavailability and bioequivalence are applied to NAS/NRC reviewed topicals which have been found to be effective. Therefore, such data were neither required nor submitted.
VI. HUMAN SAFETY:
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this NADA. The drug is approved for use only on dogs, cats and horses (not for food use) and is labeled:
Warning: Do not use on horses intended for food.
Human safety relative to possession, handling, and administration:
Labeling contains adequate warning statements.
Carcinogenesis: Nitrofurazone has been shown to produce mammary tumors in rats and ovarian tumors in mice.
Some people may be hypersensitive to this product. Either wear gloves when applying, or wash hands afterwards."
In addition, the labeling contains the following statement:
"KEEP OUT OF REACH OF CHILDREN "
VII. AGENCY CONCLUSIONS:
The data submitted in support of this NADA comply with the conclusions of NAS/NRC review as concurred in by FDA and with CVM's policy concerning bioequivalence of topical drugs and demonstrate that NFZ Wound Powder (0.2% nitrofurazone soluble powder) when used under its approved conditions of use, is safe and effective for the prevention or treatment of bacterial infections of wounds, burns, skin ulcers and abscesses after incision on dogs, cats and horses (not for food use).
The drug is labeled for over the counter (OTC) use for the following reasons:
- It is a generic topical antibacterial preparation with a long OTC marketing history of safe and effective use for the above indications.
- A diagnosis by a veterinarian is not necessary, as the labeled use conditions are easily recognized by the layman.
In view of the above, it is approved for OTC marketing because adequate directions for use by the layman can be written.
VIII. LABELING (Attached)
- NFZ® Wound Powder product label
Copies of this label may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855