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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for June and July 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No III

CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Applications (NADAs)

PAYLEAN (ractopamine hydrochloride) and TYLAN (tylosin phosphate) (NADA 141-172), filed by Elanco Animal Health, a Division of Eli Lilly & Co. The original NADA provides for the use of two-way combination Type B and Type C medicated swine feeds formulated with PAYLEAN (ractopamine hydrochloride) and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles. The supplement provides for revised indications for the use of Type C medicated feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness; and for the control of swine dysentery associated with Brachyspira hyodysenteriae and porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis in finishing swine, weighing not less than 150 lbs., fed a complete ration containing at least 16 percent crude protein for the last 45-90 lbs. of gain prior to slaughter. Notice of approval was published July 31, 2007.

IVOMEC (ivermectin) (NADA 140-974), filed by Merial LTD. The supplemental NADA provides for the use of IVOMEC (ivermectin) Premix for Swine, a Type A medicated article, for the treatment and control of various internal and external parasites. The supplement revised the approved concentration of ivermectin in Type C medicated feed administered as a top dress to adult and breeding swine. Notice of approval was published July 10, 2007.

DERAMAXX (deracoxib) (NADA 141-203), filed by Novartis Animal Health US, Inc. The supplemental NADA provides for the addition of a 75-mg size of DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and inflammation in dogs. Notice of approval was published July 10, 2007.

LINCOMIX 20 (lincomycin hydrochloride) and LINCOMIX 50 (NADA 97-505), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for the use of LINCOMIX 20 and LINCOMIX 50 Feed Medications in single-ingredient Type B and Type C medicated feeds for swine weighing greater than 250 lbs. and for the addition of a reproductive caution statement to the labeling. Notice of approval was published June 18, 2007.

ADSPEC (spectinomycin sulfate) Sterile Solution (NADA 141-077), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The original NADA was approved for the use of ADSPEC (spectinomycin sulfate) for the treatment of bovine respiratory disease associated with several bacterial pathogens. The supplemental NADA provides for revising nomenclature for two bacterial pathogens on product labeling for spectinomycin sulfate injectable solution. Notice of approval was published June 6, 2007.