Approval Date: February 18, 1987
I. GENERAL INFORMATION
Squire Laboratories, Inc.
100 Mill Street
Revere, Massachusetts 02151
0.2% nitrofurazone dressing (water soluble)
Fura-Zone Solution, Brand of Nitrofurazone Soluble Dressing
Over the Counter (OTC)
II. INDICATION FOR USE
For use only on dogs, cats, and horses (not intended for food use). For the prevention or treatment of surface bacterial infections of wounds, burns, cutaneous ulcers and abscesses after incision.
A. DOSAGE FORM: a water soluble solution.
B. ROUTE OF ADMINISTRATION: topical.
C. RECOMMENDED DOSAGES: Apply directly on the lesion. For wet dressings, it may be diluted with two or three parts of sterile water or saline solution. This may be applied several times daily or left beneath the occlusive dressing for several days.
IV. ANIMAL EFFECTIVENESS AND SAFETY
Nitrofurazone Solution (Furacin Solution, NADA 006-475) 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 and cutaneous ulcers. Due to concern for the safety of residues from food-producing animals, FDA concluded that the 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 the applications providing for the effective conditions of use identified in that notice need not include data required by 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 waiver 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.
V. 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 intended for food use) and is labeled: "Not for use on horses intended for food."
Human safety relative to possession, handling, and administration:
Labeling contains adequate caution statement.
VI. AGENCY CONCLUSION
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 Fura-Zone (nitrofurazone) Solution 0.2%, when used under its approved conditions of use is safe and effective for the prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers on dogs, cats, and horses not intended for food.
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 laymen.
In view of the above, it is approved for over-the-counter marketing because adequate directions for use by laymen can be written.
VII. LABELING (Attached)
- 1 Gallon Container label
Copies of this label may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.