NADA 120-614 Tylan 5, 10, 20, and 40 Sulfa-G - original approval

Approval Date: May 28, 1985

I. GENERAL INFORMATION

II. INDICATIONS FOR USE

For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.

III. DOSAGE FORM(S), ROUTE OF ADMINISTRATION AND RECOMMENDED DOSAGE

Medicated Premix
The premix is to be added to the feed such that the complete feed contains 100 grams of tylosin and 100 grams of sulfamethazine per ton.

IV., V. & VI. EFFECTIVENESS, ANIMAL SAFETY AND HUMAN SAFETY

The safety and efficacy data upon which this application was approved are found in NADA 12-491 and 41-275 for Elanco Products Company, and are summarized in an FOI Summary filed with the Dockets Management Branch under the generic name of the drugs.

VII. AGENCY CONCLUSION

Approval of this application is based on safety and effectiveness data contained in Elanco Products Company's approved NADA's 12-491 and 41-275. Use of the data in NADA's 12-491 and 41-275 to support this application has been authorized by Elanco. 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 II supplemental approval which does not require reevaluation of the safety and effectiveness data in the original approval.

VIII. LABELING (Attached)

1. Bag labels for all four concentrations of drug.

Copies of applicable 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.