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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals: January 1, 2010 to April 5, 2010


Original New Animal Drug Applications (NADAs)

TOPMAX (ractopamine hydrochloride) & COBAN (monensin, USP) (NADA 141-301), filed by Elanco Animal Health, A Division of Eli Lilly & Co.  The original NADA provides for use of single-ingredient Type A medicated articles containing ractopamine hydrochloride and monensin to formulate two-way combination Type C medicated feeds for finishing hen and tom turkeys.  Notice of approval published February 5, 2010.

SUROLAN (miconazole nitrate, polymixin B sulfate, and prednisolone acetate) (NADA 141-298), filed by Janssen Pharmaceutica NV.  The original NADA provides for use of miconazole nitrate, polymixin B sulfate, and prednisolone acetate for the treatment of otitis externa in dogs.  Notice of approval published January 29, 2010.

RESFLOR GOLD (florfenicol and flunixin meglumine) (NADA 141-299), filed by Intervet, Inc.  The original NADA provides for use of a combination injectable solution containing florfenicol and flunixin meglumine (in 2-pyrrolidone and triacetin) for the treatment of respiratory disease and control of associated pyrexia in beef and non‑lactating dairy cattle.  Notice of approval published January 11, 2010.

Supplemental New Animal Drug Applications (NADAs):

DURAMYCIN-10 (tetracycline hydrochloride) (NADA 65-140), filed by Alpharma, Inc.  The supplemental NADA provides for revised labeling for a 25 gram per pound concentration of tetracycline hydrochloride soluble powder used to make medicated drinking water for calves, swine, chickens, and turkeys for the treatment and control of various bacterial diseases.  Notice of approval published March 18, 2010.

MICOTIL 300 (tilmicosin injection, USP) (NADA 140-929), filed by Elanco Animal Health, A Division of Eli Lilly & Co.  The supplemental NADA provides for a dose range of an injectable solution of tilmicosin phosphate for the treatment and control of respiratory disease in beef and non-lactating dairy cattle and the addition of pathogens to the treatment of respiratory disease claim in beef and non-lactating dairy cattle.  Notice of approval published March 2, 2010. 

CHLORATET 50 (chlortetracycline) (NADA 48-480), filed by ADM Alliance Nutrition, Inc.  The supplemental NADA provides for use of a higher concentration chlortetracycline Type A medicated article for the manufacture of medicated feeds for chickens, turkeys, swine, and cattle.  Notice of approval published March 2, 2010.

EXCEDE (ceftiofur crystalline free acid) Sterile Suspension (NADA 141-209), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc.  The supplemental NADA provides for use of ceftiofur crystalline free acid injectable suspension for the treatment of lower respiratory tract infections in horses.  Notice of approval published January 29, 2010.
OPTAFLEXX 45 (ractopamine hydrochloride) (NADA 141-221), filed by Elanco Animal Health, A Division of Eli Lilly & Co.  The supplemental NADA provides for administering ractopamine hydrochloride Type C medicated feeds as a top dress to cattle fed in confinement for slaughter.  Notice of approval published January 11, 2010.                          

Abbreviated New Animal Drug Applications (ANADAs):

FLUNAZINE-S (flunixin meglumine) Injectable Solution (ANADA 200-489), filed by Cross Vetpharm Group Ltd.  The ANADA provides for use of flunixin meglumine injectable solution for the control of pyrexia associated with respiratory disease in swine.  Notice of approval published March 19, 2010.

ZILMAX (zilpaterol hydrochloride), HEIFERMAX 500 (melengestrol acetate) Liquid Premix, RUMENSIN (monensin USP), and TYLAN (tylosin phosphate) (ANADA 200-483, ANADA 200-479, and ANADA 200-480), filed by Ivy Laboratories, Div. of Ivy Animal Health, Inc.  The three original ANADAs provide for use of single-ingredient Type A medicated articles containing zilpaterol, melengestrol, monensin, and tylosin to make two-way, three-way, and four-way combination drug Type B and Type C medicated feeds for heifers fed in confinement for slaughter.  Notice of approval published March 11, 2010.

ALBAC 50 (bacitracin zinc) and NICARB (nicarbazin) (ANADA 200-478), filed by Alpharma, Inc.  The original ANADA provides for use of single-ingredient Type A medicated articles containing bacitracin zinc and nicarbazin to make two-way combination drug Type C medicated feeds for broiler chickens.  Notice of approval published February 22, 2010

SEVOFLO (sevoflurane) (ANADA 200-467), filed by Halocarbon Products Corp.  The original ANADA provides for use of sevoflurane inhalant anesthetic in dogs.  Notice of approval published January 8, 2010.