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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - July and August 2002

FDA Veterinarian Newsletter 2002 Volume XVI, No IV

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Alpharma, Inc.
(NADA 141-124)

Nicarbazin, Narasin,
Bacitracin Methylene Disalicylate (Maxiban plus BMD®)

Broiler Chickens. For the prevention of coccidiosis and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.

MEDICATED FEED-The NADA provides for using approved two-way narasin/nicarbazin and single-ingredient bacitracin methylene disalicylate Type A medicated articles to make three-way, combination drug Type C medicated feeds for broiler chickens. The Type C feeds are used for the prevention of coccidiosis caused by Eimera tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Federal Register 05/06/02

Alpharma, Inc.
(NADA 141-154)

Robenidine Hydrochloride, Bacitracin Methylene Disalicylate (Robenz® plus BMD®)

Broiler and fryer chickens. For the prevention of coccidiosis and as an aid in the prevention or control of necrotic enteritis.

MEDICATED FEED- The NADA provides for use of approved single-ingredient Bacitracin methylene disalicylate (BMD) and robenidine hydrochloride Type A medicated articles to make two-way combination Type C medicated broiler and fryer chicken feeds. The combination Type C medicated feeds are used for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima.
Federal Register 05/07/02

Schering-Plough Animal Health
(NADA 141-190)

Diclazaril, Bacitracin Methylene Disalicylate, Roxarsone (Clinacox plus BMD® plus 3-Nitro®)

Broiler chickens. For the prevention of coccidiosis, as an aid in the prevention or control of necrotic enteritis, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

MEDICATED FEED-The NADA provides for use of approved single-ingredient diclazuril, bacitracin methylene disalicylate, and roxarsone Type A medicated articles to make 3-way combination drug Type C medicated feeds for broiler chickens. The Type C medicated feeds are used for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima.
Federal Register 05/16/02

Alpharma, Inc.
(NADA 141-185)

Decoquinate, Chlortetracycline (Deccox® plus Aureomycin®)

Calves, beef, and non-lactating dairy cattle. For the prevention of coccidiosis, treatment of bacterial enteritis, and treatment of bacterial pneumonia.

MEDICATED FEED-The NADA provides for use of approved decoquinate and chlortetracyline Type A medicated articles to make two-way combination Type B and Type C medicated feeds for calves, beef, and nonlactating dairy cattle. The combination Type C feeds are used for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, for the treatment of bacterial enteritis caused by escherichia coli, and for treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Federal Register 05/23/02