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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - July and August 2002

FDA Veterinarian Newsletter 2002 Volume XVI, No IV

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Monsanto Co.
(NADA 140-872)

Sometribove Zinc (Posilac 1 Step®)

Dairy cows. To increase the production of marketable milk with no restriction on injection site.

SUBCUTANEOUS-The supplement provides for subcutaneous injection with no restriction on injection site. Three sites are recommended: the neck area, the postcapular region, or the depression on either side of the tailhead.
Federal Register 04/15/02

Elanco Animal Health
Division of Eli Lilly & Co.
(NADA 141-064)

Tilmicosin (Pulmotil®) Rx

Swine. For the control of swine respiratory disease associated with certain bacterial organisms.

MEDICATED FEED-The supplement provides for additional use information in labeling. The expiration date of Veterinary Feed Directives (VFD's) for tilmicosin must not exceed 90 days from time of issuance. VFD's for tilmicosin shall not be refilled. Do not use in Type B or C medicated feeds containing bentonite. Do not allow horses or other equines access to feeds containing tilmicosin.
Federal Register 05/02/02

Pharmacia & Upjohn Co.
(NADA 97-505)

Lincomycin (Lincomix 20 & 50)

Swine. For the control of porcine proliferative enteropathies (ileitis).

MEDICATED FEED- The supplement provides for use of Lincomix 20 and 50 feed medications in medicated swine feeds for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis.
Federal Register 05/24/02