ANADA 200-203 Carb-O-Sep®, Albac® - original approval

Approval Date: September 22, 1997

I. GENERAL INFORMATION

Established Name:

• Carbarsone
• Bacitracin zinc

Trade/Proprietary Name:

• CARB-O-SEP^®
• ALBAC^®

Dosage Form: Type A medicated articles

NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (CARB-O-SEP^® and ALBAC^®) in Type C medicated feeds, rather than a premix incorporating both of these compounds.

How Supplied:

• Carbarsone: 50-lb bags
• Bacitracin zinc: 50-lb bags

How Dispensed: OTC

Label Claim of Amount of Active Ingredient(s):

• Carbarsone: 170.25 g/lb of carbarsone in Type A medicated article
• Bacitracin zinc: 50 g/lb bacitracin zinc in Type A medicated article

Route of Administration: These drugs are administered orally by adding the Type A medicated articles to complete turkey feed (Type C medicated feed).

Labeled Dosage:

• Carbarsone: 227 to 340.5 g/ton
• Bacitracin zinc: 4 to 45 g/ton

Species: Growing turkeys

Indications for Use: As an aid in the prevention of blackhead, and for increased rate of weight gain and improved feed efficiency.

Generic Product:

• ALBAC^®
  Bacitracin zinc
  ANADA 200-223
  ALPHARMA, Inc.

Pioneer Product/"Listed" Product:

• BACIFERM^®
  Bacitracin zinc
  NADA 46-920
  Hoffmann-La Roche, Inc.
• CARB-O-SEP^®
  Carbarsone
  NADA 10-285
  ALPHARMA, Inc.
• CARB-O-SEP^®/BACIFERM^®
  Carbarsone/bacitracin zinc
  NADA 136-484
  Hoffmann-La Roche, Inc.

II. EFFECTIVENESS AND TARGET ANIMAL SAFETY

In accordance with the Center for Veterinary Medicine's policy letter dated November 2, 1989, as published in the Federal Register on January 30, 1990 (55 FR 3107), following the approval of an ANADA for a generic Type A Medicated article (ANADA 200-223, generic bacitracin zinc), ALPHARMA, Inc., is entitled to the approval of generic bacitracin zinc in combination with carbarsone. Bioequivalence studies are not required for the approval of this generic combination (Type C Medicated feed). Bacitracin zinc is codified under 21 CFR §558.78. Carbarsone is codified under 21 CFR §558.120. The combination of bacitracin zinc and carbarsone is codified under 21 CFR §558.120(c)(1)(iii). [21 CFR §558.120(c) is redesignated 21 CFR §558.120(d) concurrent with this approval].

III. HUMAN SAFETY

Tolerances for the Marker Residue
The tolerances established for the pioneer bacitracin zinc product apply to the generic bacitracin zinc product.

The tolerances for residues of bacitracin from bacitracin zinc are established at 0.5 ppm (0.02 unit per gram), negligible residue, in uncooked edible tissues of turkeys (21 CFR §556.70).

Tolerances for arsenic residues (from carbarsone) are established at 0.5 ppm in uncooked muscle and 2 ppm in uncooked edible by-products of turkeys (21 CFR §556.60)

Withdrawal Time
Based on the information in 21 CFR §558.120(c)(1)(iii) [redesignated 21 CFR §558.120(d)(1)(iii) concurrent with this approval], a 5-day withdrawal time is required for the use of the combination of bacitracin with carbarsone in turkeys.

Regulatory Method for Residues
The regulatory analytical method for detection of residues of bacitracin is a microbiological test using Sarcina subflava (ATCC 7468) or Micrococcus subflavus (ATCC 10240). The method is found in Antibiotic Residues in Milk, Dairy Products, and Animal Tissues: Methods, Reports and Protocols, Revised October 1968, Reprinted December 1974, National Center for Antibiotic and Insulin Analysis, FDA, Washington DC 20204

Modified Method for the Determination of Bacitracin in Tissues, Test Procedure Code 9A, AL Laboratories, One Executive Dr, PO Box 1399, Fort Lee NJ 07024.

The analytical method for the determination of carbarsone in tissues is a spectrophotometric method. The method is entitled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method" published in Official Methods of Analysis of AOAC International, 16th edition.

IV. AGENCY CONCLUSIONS

This ANADA submitted under section 512(b) of the Federal Food, Drug, and Cosmetic Act satisfies the requirements of section 512(n) of the act and demonstrates that the combination of carbarsone and bacitracin zinc, when used under its proposed conditions of use, is safe and effective for its labeled indications.

Attached labeling:

1. Type C medicated Feed (Blue Bird) - Generic
2. Type C medicated Feed (Blue Bird) - Pioneer

Copies of applicable labels may be obtained by writing to the:

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855