Approval Date: August 5, 1987
Freedom of Information Summary
NADA 140-842
I. GENERAL INFORMATION:
NADA 140-842 Sponsor: MacPage, Inc.
1600 South Wilson Avenue
Dunn, North Carolina 28334Generic Name: hygromycin B Trade Name: Hygromix 2.4 Premix 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 three 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.
IV. 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 Company, 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 2.4 package label
Copies of this label may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855