Approval Date: March 5, 1996

Freedom of Information Summary
NADA 200-171

I. GENERAL INFORMATION:

NADA	200-171
Sponsor:	Planalquimica Industrial Ltda. Rua das Magnólias nr. 2405 Jardim das Bandeiras CEP 13053-120 Campinas - Sao Paulo - Brazil
Generic Name:	Nicarbazin, Lincomycin hydrochloride monohydrate
Trade Name:	Nicarmix 25®, Lincomix®
Marketing Status:

a. Established Name:

Nicarbazin
Lincomycin hydrochloride monohydrate

b. Trade/Proprietary Name:

Nicarmix 25®
Lincomix®

c. Dosage Form: Type A medicated articles

NOTE: This ANADA provides for the combined use of two approved Type A medicated articles (Nicarmix 25® and Lincomix®) in Type C medicated feeds, rather than a premix incorporating all of these compounds.

d. How Supplied:

Nicarbazin: 50-lb bags
Lincomycin: 50-lb bags

e. How Dispensed: OTC

f. Label Claim of Amount of Active Ingredient(s):

Nicarbazin: 113.5 g/lb of Type A medicated article
Lincomycin: 4, 20 and 50 g/lb of Type A medicated article

g. Route of Administration:

These drugs are administered orally by adding the Type A medicated articles to complete broiler feed (Type C medicated feed).

h. Labeled Dosage:

Nicarbazin: 113.5 g/ton
Lincomycin: 2 g/ton

i. Species: Broiler Chickens

j. 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 gain in broiler chickens.

k. Generic Product:

Nicarmix 25®
Nicarbazin
ANADA 200-027
Planalquimica Industrial Ltda.

l. Pioneer Product/ "Listed" Product:

NICARB®
nicarbazin
NADA 009-476
Merck Research Laboratories

Lincomix®
Lincomycin
NADA 034-085
The Upjohn Company

NICARB®/Lincomix®
Nicarbazin/Lincomycin
NADA 108-116
Merck Research Laboratories

2. 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 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. The combination of nicarbazin and lincomycin is codified under 21 CFR §558.325(c)(3)(xii) and §558.366(c).

3. 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.

A tolerance for residues of lincomycin in chickens is not required under 21 CFR §556.360.

Withdrawal Time

A 4-day withdrawal time is established for chickens receiving the combination of nicarbazin 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 Methods for Residues

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.

4. 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 and lincomycin, when used under its proposed conditions of use, is safe and effective for its labeled indications.

Attachments:

1) Blue Bird label for the generic Type C medicated feed for broiler chickens.
2) 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