Approval Date: June 18, 1985
Freedom of Information Summary
NADA 138-453
I. GENERAL INFORMATION:
NADA 138-453 Sponsor: Southern Micro Blenders, Inc.
3801 North Hawthorne Street
Chattanooga, Tennessee 37406Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes Marketing Status: 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 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Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.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
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. SUMMARY OF SAFETY AND EFFICACY
The safety and efficacy data upon which this application was approved are found in NADAs 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.
V. AGENCY CONCLUSION
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 Center for Veterinary Medicine'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 application.
VI. LABELING (Attached)
1. Tylan 40 Sulfa-G(TM) package label
2. Tylan 20 Sulfa-G(TM) package label
3. Tylan 10 Sulfa-G(TM) package label
4. Tylan 5 Sulfa-G(TM) 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.