Approval Date: November 18, 1995
Freedom of Information Summary
NADA 139-239
I. GENERAL INFORMATION:
NADA 139-239 Sponsor: Growmark, Inc.
1701 Towanda Avenue
Bloomington, Illinois 61701Generic Name: pyrantel tartrate Trade Name: SWINE-GUARD-BN Banminth Premixes Marketing Status: II. INDICATIONS FOR USE
1. Continuous Feeding Program:
For aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; for aid in the prevention of establishment of nodular worm (Oesophagostomum) infections of swine. Feed continuously as the sole ration.
2. 3-Day Therapeutic Program:
For the removal and control of large roundworm (Ascaris suum) infections of swine. Feed for three days as the sole ration.
3. Single Therapeutic Program:
For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) infections of swine.
4. Withdraw this feed 24 hours prior to slaughter.
III. DOSAGE FORM
Medicated Premix:
The premix is to be added to the feed such that the complete feed contains pyrantel tartrate equivalent to 96 grams (0.0106%) per ton of complete feed or 800 grams (0.0881%) per ton of complete feed.
IV. SUMMARY OF SAFETY AND EFFECTIVENESS DATA
The safety and effectiveness data upon which this application was approved are found in NADA 43-290 for Pfizer, Inc., and are summarized in an FOI Summary in Docket Number 75N0217.
V. AGENCY CONCLUSIONS
Approval of this application relies on safety and effectiveness data contained in Pfizer's approved NADA 43-290. Use of the data in NADA 43-290 to support this application has been authorized by Pfizer. This approval does not change the approved use of the drug. Consequently, approval of this NADA poses no increased human risk form exposure to residues of this 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), the approval of this NADA has been treated as would approval of a Category II change and did not require reevaluation of the safety and effectiveness data in NADA 43-290.
VI. LABELING (Attached)
1. 5 lb. bag label, 4.2% Pyrantel Tartrate
2. 10 lb. bag label, 2.1 % Pyrantel Tartrate
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.