Approval Date: May 30, 1986

Freedom of Information Summary
NADA 140-443

I. GENERAL INFORMATION:

NADA	140-443
Sponsor:	Arkansas Micro Specialties, Inc. Hwy 71 North PO Box 308 Lowell, Arkansas 72745
Generic Name:	hygromycin B
Trade Name:	Hygromix 0.6 and 1.6 Premixes
Marketing Status:

II. INDICATIONS FOR USE

Swine:

Control of infestations of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis).

Chickens:

Control of infestations of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata).

Discontinue swine feeds containing Hygromycin B 15 days before slaughter.

Discontinue chicken feeds containing Hygromycin B 3 days before slaughter.

III. DOSAGE FORM

Medicated premix.

The premixes are to be added to the feed such that the complete feed contains either 8 grams or 12 grams of hygromycin B per ton.

VI. SUMMARY OF SAFETY AND EFFICACY

The safety and efficacy data upon which this application was approved are found in NADAs 10-918 and 11-948 for Elanco Products Co., and are summarized in an FOI Summary filed with the Dockets Management Branch (HFA-305) under the generic name of the drug.

V. AGENCY CONCLUSIONS

Approval of this application is based on safety and effectiveness data contained in Elanco's approved NADAs 10-918 and 11-948. This approval does not change the approved use of the drug. Consequently, approval of this NADA poses no increased human risk from exposure to residues of the animal drug, nor does it change the conditions of the drug's safe use in the target animal species. Accordingly, under the Center's supplemental approval policy (42 FR 64367), this is equivalent to a Category 2 supplemental approval, which does not require reevaluation of the safety and effectiveness data in the original applications.

VI. LABELING

1. Hygromix 1.6 package label
2. Hygromix 0.6 package label

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