Approval Date: August 2, 1989
I. GENERAL INFORMATION:
601 West Cornhusker Highway
Lincoln, Nebraska 68521
nystatin - neomycin sulfate - thiostrepton - triamcinolone - acetonide topical ointment
DERMA 4 Ointment
II. INDICATIONS FOR USE
DERMA 4 Ointment is particularly useful in the treatment of: (1) acute and chronic otitis of varied etiologies; (2) interdigital cysts in dogs and cat; (3) anal gland infections in dogs; (4) dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal (Candida albicans ) infection; and (5) eczematous, contact and seborrheic dermatitis. Additionally, DERMA 4 Ointment may be used as an adjunct in the treatment of dermatitis due to parasitic infestation.
III. DOSAGE AND ADMINISTRATION
The frequency of DERMA 4 Ointment administration is dependent on the severity of the condition. Application may range from once daily to once weekly for mild inflammation, or two to three times daily for severe conditions. Frequency of treatment may be decreased as improvement occurs.
Recommended treatment dosages are as follows:
The impacted cerumen of the ear canal must be cleaned, including removal of any foreign bodies such as grass awns, ticks, etc. Administer three to five drops of DERMA 4 Ointment. Preliminary use of a local anesthetic may be advisable.
Infected Anal Glands, Cystic Areas, etc.:
The gland or cyst is drained and then filled with DERMA 4 Ointment.
Other Dermatologic Disorders:
The affected areas are cleaned and any encrusted discharge or exudate is removed. DERMA 4 Ointment is applied sparingly in a thin film.
DERMA 4 Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide) is chemically identical to Panalog Ointment (NADA 12-258, Solvay Veterinary, Inc., formerly E.R. Squibb & Sons, Inc.) which was the subject of a review by the National Academy of Science/National Research Council (NAS/NRC), Drug Efficacy Study Group. 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. This was published in a Federal Register Notice, Volume 35, No. 166, Wednesday, August 26, 1970. It was also codified in 21 CFR 524.1600a.
The DERMA 4 Ointment labeling contains the same claims as those contained on the labeling for Panalog Ointment, the pioneer product. In addition, the DERMA 4 Ointment labeling includes the safety information required by CVM in the Federal Register announcement of December 13, 1984 covering drug products containing a steroid.
Under the policy of the Center for Veterinary Medicine, the principles of 21 CFR 320.22, providing for a waiver of the requirement for submission of evidence of in vivo bioavailability/bioequivalence,are applicable to NAS/NRC reviewed topically applied veterinary new animal drug preparations intended for local therapeutic effect. 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.
V. ANIMAL SAFETY
Reference is again made to the NAS/NRC review of Panalog Ointment. 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). In addition, the DERMA 4 Ointment labeling includes the safety information required by CVM in the Federal Register announcement of December 13, 1984 covering drug products containing a steroid. Likewise, the safety of this combination has been proven in over 25 years of continuous veterinary use.
VI. HUMAN FOOD SAFETY:
Data on human safety, pertaining to consumption of drug residues in food, were not required of reapproval of this NADA. The product is labeled as a prescription drug for use only on dogs and cats; which are non-food animals.
Human Safety Considerations Other Than Food Safety:
In regard to possession, handling and administration, adequate information is provided under the headings "warning", "precautions", and "side effects" on the package insert for the safe use of the product by veterinarians and to instruct their clients on its proper and safe use.
VII. AGENCY CONCLUSIONS:
The data submitted in support of this NADA comply with the conclusions of the NAS/NRC review, as concurred with by FDA, and with CVM's policy concerning topical drugs. The data demonstrated that DERMA 4 Ointment, when used under its approved conditions of use, is safe and effective for the treatment of acute and chronic otitis of varied etiologies, for interdigital cysts in cats and dogs, for anal gland infections in dogs, for management of moist or dry dermatologic disorders characterized by inflammation: bacterial, candidal (Candida albicans ), contact, eczematous, seborrheic, and parasitic (ear mites).
The labeling for this product contains the veterinary prescription legend because the expertise of a veterinarian is necessary for diagnoses of the etiologies of the conditions for which the product is indicated, for proper preparation of the animals for drug administration (otitis & anal glands), for the administration of the drug (anal glands), and for supervision of the progress of the animals to reduce the potential of adverse side effects such as: SAP and SGPT (ALT) enzyme elevations, polydipsia/polyuria, vomiting, diarrhea (occasionally bloody), Cushings syndrome, and deafness.
VIII. LABELING (Attached)
- Derma 4 Ointment product label 1/4, 1/2,1, and 8 oz, tubes
- Derma 4 Ointment package label 1/4, 1/2,1, and 8 oz, tubes
- Derma 4 Ointment package insert
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855