Approval Date: May 19, 1987
I. GENERAL INFORMATION
VET LABS Limited, Inc.
Over the Counter (OTC)
II. INDICATIONS FOR USE
For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats, and horses (not for food use).
A. DOSAGE FORM: Topical ointment containing 0.2% w/w nitrofurazone in a water-soluble base.
B. ROUTE OF ADMINISTRATION: Topical
C. RECOMMENDED DOSAGES: Apply directly on the lesion with a spatula or first place on a piece of gauze. Use of a bandage is optional. The preparation should remain on the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period.
IV. and V. EFFECTIVENESS and ANIMAL SAFETY
Nitrofurazone Ointment (Furacin Dressing 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, and cutaneous ulcers. 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 waiver of the requirement for submission 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 intended 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 caution statement.
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 the Nitrofurazone Ointment 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 of 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 laymen. In view of the above, it is approved for over-the-counter marketing because adequate directions for use by laymen can be written.
- Nitrofurazone Ointment 0.2% package 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.