Animal & Veterinary
NADA 128-255 Tylan 5 Sulfa Premix, Tylan 10 Sulfa Premix - original approval
I. GENERAL INFORMATION
|Sponsor:||Kay Dee Feed Co.|
1919 Grand Avenue,
Sioux City, Iowa 51107
has an appoved NADA 128-255
|Generic Name:||tylosin, sulfamethazine|
|Trade Name:||Tylan 5 Sulfa Premix, Tylan 10 Sulfa Premix|
II. INDICATIONS FOR USE
The claims are 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 pneumonias 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 Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.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
The premixes are to be added to the feed such that the complete feed contains 100 grams of tylosin and 100 qrams 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 NADAs 12-49l and 4l-275 for Elanco Products Company, and are summarized in a FOI Summary filed with the Hearing Clerk under the generic name of the drug.
VII. AGENCY CONCLUSIONS
Approval of this application is based on safety and effectiveness data contained in Elanco Products Company's approved NADAs 12-491 and 41-275. Use of the data in NADAs 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 Bureau of Veterinary Medicine's supplemental approval policy (42 FR 64367), approval of this NADA has been treated as would approval of a Category II supplemental NADA and does not require reevaluation of the safety and effectiveness in NADAs 12-491 and 41-275.
VIII. LABELING (Attached)
- Tylan® 10 sulfa medicated premix product label
- Tylan® 5 sulfa medicated premix product 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.