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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for December 2006 and January 2007

FDA Veterinarian Newsletter January/February 2006 Volume XVII, No VI

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

SLENTROL (dirlotapide) Oral Solution (NADA 141-260), filed by Pfizer, Inc. The NADA provides for the veterinary prescription use of dirlotapide solution in dogs for the management of obesity. Notice of approval was published January 4, 2007.

DEXDOMITOR (dexmedetomidine hydrochloride) (NADA 141-267), filed by Orion Corp. The NADA provides for the veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a sedative, analgesic, and pre-anesthetic in dogs. Notice of approval was published January 4, 2007.

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

RESPIRAM (doxapram hydrochloride), an injectable solution (ANADA 200-435), filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of RESPIRAM (doxapram hydrochloride) in dogs, cats, and horses to stimulate respiration during and after general anesthesia. Modern Veterinary Therapeutics’ RESPIRAM is approved as a generic copy of DOPRAM-V Injectable, sponsored by Fort Dodge Animal Health, Division of Wyeth, under NADA 034-879. Notice of approval was published January 4, 2007.

GENTAMICIN SULFATE INJECTION (ANADA 200-394), filed by Sparhawk Laboratories. The ANADA provides for the use of Gentamicin Sulfate Injection in piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of Escherichia coli sensitive to gentamicin. Sparhawk Laboratories’ Gentamicin Sulfate Injection is approved as a generic copy of Schering-Plough Animal Health Corp.’s GARACIN Piglet Injection, approved under NADA 103-037. Notice of approval was published December 22, 2006.

PRIMEX (pyrantel pamoate) (ANADA 200-445), filed by First Priority, Inc. The ANADA provides for the use of pyrantel pamoate in horses and ponies as an OTC animal drug product for the removal and control of various internal parasites. First Priority, Inc.’s, PRIMEX Horse Wormer is approved as a generic copy of Pfizer, Inc.’s, PAMOBAN Horse Wormer, approved under NADA 91-739. Notice of approval was published -December 4, 2006.

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

RUMENSIN 80 (Monensin) Type A medicated articles (NADA 95-735), filed by Elanco Animal Health, a Division of Eli Lilly & Co. The supplemental NADA provides for the use of an increase in the upper dose limit of monensin to 40 g/ton (480 mg/hd/day) in Type C medicated feeds used for improved feed efficiency, and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in cattle fed in confinement for slaughter. Notice of approval was published January 8, 2007.

NOLVASAN (chlorhexidine acetate) (NADA 9-782), filed by Fort Dodge Animal Health, a Division of Wyeth. The supplemental NADA provides for the revision of labeling of the product, which is approved for the use of (chlorhexidine acetate) Antiseptic Ointment as a topical antiseptic for superficial wounds of dogs, cats, and horses. The supplement provides for a revised food safety warning on labeling, specifically to warn against the use of the product in horses intended for human consumption. Notice of approval was published January 4, 2007.

ANTISEDAN (atipamezole hydrochloride) (NADA 141-033), filed by Orion Corp. The supplemental NADA adds a claim for reversal of sedative and analgesic effects of dexmedtomidine hydrochloride to labeling for atipamezole hydrochloride injectable solution, which is already approved for reversal of the sedative and analgesic effects of medeto-midine hydrochloride in dogs. Notice of approval was published January 4, 2007.

NUFLOR (florfenicol) 2.3% Concentrate Solution used to make medicated drinking water for administration to swine for the treatment of respiratory disease associated with several bacterial pathogens (NADA 141-206), filed by Schering-Plough Animal Health Corp. The supplemental NADA revises the nomenclature for a respiratory pathogen in the label claim. Notice of approval was published January 4, 2007.

CLOMICALM (clomipramine hydrochloride), filed by Animal Health US, Inc. (NADA 141-120). The supplemental NADA provides for the veterinary prescription use of CLOMICALM (clomipramine hydrochloride) Tablets for treatment of separation anxiety in dogs. The effect of the supplement is the addition of a 5 mg tablet size. Notice of approval was published January 4, 2007.

TYLAN (tylosin phosphate) Type A medicated articles (NADA 12-491), filed by Elanco Animal Health, A Division of Eli Lilly & Co. The supplemental NADA provides for use of TYLAN (tylosin phosphate) Type A medicated articles for an alternate feeding regimen for the control of swine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. In addition, Elanco Animal Health revised the names of other enteric pathogens of swine to reflect changes in the scientific nomenclature for these bacteria. Notice of approval was published December 12, 2006.