Approval Date: March 5, 1996
I. GENERAL INFORMATION
Planalquimica Industrial Ltda.
Rua das Magnólias nr. 2405
Jardim das Bandeiras
Campinas - Sao Paulo - Brazil
Nicarbazin, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Lincomycin hydrochloride monohydrate
Nicarmix 25®, 3-Nitro®, Lincomix®
- Established Name:
- Roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
- Lincomycin hydrochloride monohydrate
- Trade/Proprietary Name:
- Nicarmix 25®
Dosage Form: Type A medicated articles
NOTE: This ANADA provides for the combined use of three approved Type A medicated articles (Nicarmix 25®, 3-Nitro® and Lincomix®) in Type C medicated feeds, rather than a premix incorporating all of these compounds.
- How Supplied:
- Nicarbazin: 50-lb bags
- Roxarsone: 50-lb bags
- Lincomycin: 50-lb bags
- How Dispensed: OTC
- Label Claim of Amount of Active Ingredient(s):
- Nicarbazin: 113.5 g/lb of Type A medicated article
- Roxarsone: 10, 20, 50 and 80% roxarsone in Type A medicated article
- Lincomycin: 4, 20 and 50 g/lb of Type A medicated article
- Route of Administration: These drugs are administered orally by adding the Type A medicated articles to complete broiler feed (Type C medicated feed).
- Labeled Dosage:
- Nicarbazin: 113.5 g/ton
- Roxarsone: 22.7 g/ton
- Lincomycin: 2 g/ton
- Species: Broiler Chickens
- Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,and E. brunetti) coccidiosis and for increased rate of weight gain in broiler chickens.
- Generic Product:
- Nicarmix 25®
- ANADA 200-027
- Planalquimica Industrial Ltda.
- Pioneer Product/ "Listed" Product:
Merck Research Laboratories
Roxarsone (3-nitro-4-hydroxyphenylarsonic acid);
The Upjohn Company
Merck Research Laboratories
- Date of Approval: March 5, 1996
II. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS
In accordance with the Center'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 200-027; generic nicarbazin), Planalquimica Industrial Ltda. is entitled to the approval of generic nicarbazin in combination with roxarsone and lincomycin. Bioequivalence studies are not required for the approval of this generic combination (Type C medicated feed). Nicarbazin is codified under 21 CFR §558.366. Lincomycin is codified under 21 CFR §558.325. Roxarsone (3-Nitro®) is codified under 21 CFR §558.530. The combination of nicarbazin, lincomycin and roxarsone is codified under 21 CFR §558.325(c)(3)(xi) and §558.366(c).
III. HUMAN FOOD SAFETY
Tolerances for Marker Residues
The tolerance established for the pioneer product applies to the generic product.
A tolerance of 4.0 ppm is established for residues of nicarbazin in uncooked chicken muscle, liver, skin, and kidney under 21 CFR §556.445.
Tolerances for total residues of arsenic (calculated as As) from roxarsone are established for chicken tissues as 0.5 ppm in uncooked muscle and 2 ppm in uncooked edible by-products under 21 CFR §556.60.
A tolerance for residues of lincomycin in chickens is not required under 21 CFR §556.360.
A 5-day withdrawal time is established for chickens receiving the combination of nicarbazin, roxarsone, and lincomycin under 21 CFR §558.366. A tissue residue depletion study submitted under ANADA 200-027 supports the use of the pioneer drug withdrawal time for the generic nicarbazin product.
Regulatory Method for Residues
The analytical method for the determination of roxarsone in tissues is a spectrophotometric method. The method is titled "Arsenic (Total) Residues in Animal Tissues, Spectrophotometric Method," published in the 14th Edition of AOAC Official Methods of Analysis, Method 41.009, page 777.
The determinative procedure for quantifying nicarbazin residues in chicken tissues is a liquid chromatographic assay with UV detection of 4,4'-dinitrocarbanilide (DNC), the marker residue for nicarbazin. The identity of DNC is confirmed by thermospray liquid chromatography/mass spectrometry. The reference for the regulatory method is: J.L. Lewis, T.D. Macy, and D.A. Garteiz; J. Assoc. Off. Anal. Chem. 72(4): 577-581.
A regulatory method for residues of lincomycin in chicken tissues was not required under NADA 034-085 because edible tissue residue levels were all below the established safe concentration for total residues.
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 nicarbazin, lincomycin and roxarsone, when used under its proposed conditions of use, is safe and effective for its labeled indications.
Facsimile generic labeling and currently approved pioneer labeling are attached, as shown:
- Blue Bird label for the generic Type C medicated feed for broiler chickens, and
- Blue Bird label for the pioneer Type C medicated feed for broiler chickens.
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855