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U.S. Department of Health and Human Services

Animal & Veterinary

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NEW ANIMAL DRUG APPROVALS - July/August 2001

FDA Veterinarian Newsletter July/August 2001 Volume XVI, No IV

Company 

Generic and (Brand) Names 

Indications 

Routes/Remarks 

Alpharma, Inc.

(NADA 141-156)

Amprolium (Amprol), Bacitracin Methylene Disalicylate (BMD®)

Chickens. For the development of active immunity to coccidiosis, increased rate of weight gain, and improved feed efficiency.

MEDICATED FEED—The NADA provides for the use of approved, single-ingredient amprolium and bacitracin methylene disalicylate Type A medicated articles to make combination Type C medicated feeds.

Federal Register04/19/01

 

Alpharma, Inc.

(NADA 141-142)

Amprolium (Amprol), Bacitracin Methylene Disalicylate (BMD®), Roxarsone (3-Nitro®)

Chickens. For the development of active immunity to coccidiosis, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.

MEDICATED FEED—The NADA provides for use of approved, single-ingredient amprolium, bacitracin methylene disalicylate, and roxarsone Type A medicated articles to make three-way combination drug Type C medicated feeds.

Federal Register04/23/01

 

Elanco Animal Health

Division of Eli Lilly & Co.

(NADA 141-172)

Ractopamine hydrochloride (Paylean®), Tylosin (Tylan®)

Swine. Used for increased rate of weight gain, improved feed efficiency, increased carcass leanness, and for prevention and/or control of porcine proliferative enteropathies (ileitis).

MEDICATED FEED—The NADA provides for use of ractopamine and tylosin single-ingredient Type A medicated articles to make combination drug Type C medicated feeds.

Federal Register04/30/01

 

Elanco Animal Health

Division of Eli Lilly & Co.

(NADA 140-942)

Narasin / Nicarbazin (Maxiban®),

Bambermycins (Flavomycin®)

Chickens. For prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency.

MEDICATED FEED—The NADA provides for use of approved narasin/nicarbazin and bambermycins Type A medicated articles to make three-way combination Type C medicated feeds. The medicated feeds are used for prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, and E.mivati, and for increased rate of weight gain and improved feed efficiency. Do not feed to laying hens or allow adult turkeys, horses or other equines access to formulations containing narasin. Withdraw 5 days before slaughter.

Federal Register05/16/01

 

Alpharma, Inc.

(NADA 141-083)

Lasalocid (Avatec®),

Bacitracin Zinc (Baciferm®)

Chickens. For prevention of coccidiosis, increased rate of weight gain, and improved feed efficiency.

MEDICATED FEED—The NADA provides for use of approved lasalocid and bacitracin zinc Type A medicated articles to make two-way combination drug Type C medicated feeds for prevention of coccidiosis caused by Eimera tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency.

Federal Register 05/29/01