I. GENERAL INFORMATION:
| NADA |
131-675 |
| Sponsor: |
Hoechst-Roussel Agri-Vet Company
Route 202-206
P.O. Box 2500
Somerville, NJ 08876-1258 |
| Generic Name: |
Fenbendazole |
| Trade Name: |
SAFE-GUARD® Type"A" Medicated Article (Premix) |
|
Effect of Supplement:
|
This supplement provides for an additional Type A medicated article
(premix) containing 8% fenbendazole for the same indications for use
in Type C medicated swine feed as the currently approved Type A medicated
articles containing 4% and 20% fenbendazole. See 21 CFR 558.258.
|
II. INDICATIONS FOR USE
3-12 DAY TREATMENT REGIMEN (TOTAL DOSAGE 9 MG/KG BODY WEIGHT) FOR REMOVAL
OF:
Lungworms: Metastrongylus apri, Metastrongylus pudendotectus
Gastrointestinal worms:
Adult and larvae (L3, L4 stages, liver, lung,
intestinal forms) large roundworm (Ascaris suum ); nodular worms
(Oesophagostomum dentatum,O. quadrispinulatum ); small stomach worm
(Hyostrongylus rubidus ); Adult and larvae (L2, 3, 4 stages -intestinal
mucosal forms) whipworm (Trichuris suis )
Kidneyworm: Adult and larvae Stephanurus dentatus
III. DOSAGE FORM(S) AND RECOMMENDED
DOSAGE
No change in the currently approved dosage of nine (9) mg fenbendazole/kg
body weight (4.08 mg fenbendazole per pound) to be fed as the sole ration over
a period of 3 to 12 days. This supplement provides for a Type A medicated article;
containing 8% fenbendazole for use in Type C medicated swine feed.
IV. EFFECTIVENESS
No additional effectiveness studies were needed for this supplemental NADA,
because effectiveness was shown in approved NADA 131-675. See 49 F.R., p. 3846,
1/31/84; 53 F.R., p. 48533, 12/1/88; and 55 F.R., p. 48230/1, 11/20/90.
V. ANIMAL SAFETY
No additional target animal safety studies were needed for this supplemental
NADA, because TAS was shown in the approved NADA 131-675 (49 F.R., p. 3846,
1/31/84).
VI. HUMAN SAFETY:
No additional human safety studies were needed for this supplemental NADA,
because human food safety was shown in NADA 131-675 (49 F.R., p. 3846,
1/31/84).
VII. AGENCY CONCLUSIONS:
This supplemental NADA provides for the addition of a Type A medicated article
containing 8% fenbendazole. The formulation is not different from the 4% and
20% articles already approved except for the concentration of fenbendazole
(8%).
Under the Center's supplemental approval policy (55 F.R., p. 46045; 11/1/90)
this is a Category II change which provides for a Type A medicated article
concentration for the manufacture of Type C medicated swine feed. This change
is not expected to have an adverse affect on the safety and effectiveness of
this new animal drug. This action did not require a reevaluation of the
underlying safety and effectiveness data in the parent application.
Under the Generic Animal Drug and Patent Term Restoration Act of 1988, this
approval does not qualify for an exclusivity period under Section
512(c)(2)(f)(iii) because the active ingredient in this product has been
approved under Section 512(b) of the FD&C Act for the same indications at
the same dose as approved NADA 131-675 (49 F.R., p. 3856, 1/31/84).
VIII. LABELING (Attached)
1. Front panel package label
2. Back panel package label
Copies of these labels 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.
