Recent Animal Drug Approvals




Source: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/ucm363948.htm
August 10, 2018 NADA 141-488 Zoetis Inc. Avatec® and LINCOMIX® Broiler chickens For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. FOI Summary
August 9, 2018 ANADA 200-630 Aurora Pharmaceutical, LLC CocciAid™ Growing chickens, turkeys and laying hens For the treatment of coccidiosis. FOI Summary
August 8, 2018 NADA 141-439 Elanco US Inc. Inteprity™ Broiler chickens This supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.

FOI Summary

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FONSI

August 3, 2018 NADA 141-461 Aratana Therapeutics, Inc. NOCITA® Cats This supplement provides for use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy in cats. FOI Summary
July 30, 2018 ANADA 200-608 Piedmont Animal Health Baytril® Soft Chewable Tablets Dogs and cats For the management of diseases associated with bacteria susceptible to enrofloxacin. FOI Summary
July 13, 2018 NADA 141-406 Merial, Inc. NexGard® Dogs This supplement provides for the addition of the indication for the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks. FOI Summary
July 13, 2018 ANADA 200-484 Huvepharma EOOD Tylovet® 40 Beef Cattle and Swine This supplemental approval provides for the addition of a 40 g/lb strength of this Type A medicated article. FOI Summary
July 11, 2018 NADA 138-952 Elanco US Inc. Maxiban™ 72 Broiler chickens This supplement revises the tissue residue tolerance for nicarbazin from 4 ppm to 52 ppm, and reduces the withdrawal period for Maxiban™ 72 from five days to zero days.

FOI Summary

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July 6, 2018 ANADA 200-495 Norbrook Laboratories, Ltd. Enroflox® 100 Swine The effect of the supplement provides for the addition of the use of the drug via intramuscular injection in swine, the addition of two pathogens, Bordetella bronchiseptica and Mycoplasma hyopneumoniae, to the swine respiratory disease (SRD) treatment and control indications and the addition of indications for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed. FOI Summary
July 2, 2018 ANADA 200-624 Modern Veterinary Therapeutics, LLC REVERTIDINE™ Dogs For the reversal of the sedative and analgesic effects of dexmedetomidine
hydrochloride, and medetomidine hydrochloride in dogs.
FOI Summary
June 14, 2018 NADA 098-379 Merial, Inc. CYSTORELIN® Lactating dairy cows and beef cows This supplement provides for the addition of a new indication ‘For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.’

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June 6, 2018 NADA 141-342 Jurox Pty. Ltd. Alfaxan® Multidose Cats and Dogs This supplement provides for the addition of preservatives to the formulation and use of a multidose vial. FOI Summary
May 31, 2018 NADA 141-495 Elanco US Inc. Inteprity™ and Bio-Cox® Broiler chickens For the prevention of mortality caused by necrotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati in broiler chickens. FOI Summary
May 25, 2018 NADA 141-063 Intervet, Inc. Nuflor® Cattle (beef and non-lactating dairy) This supplement provides information to address the human food safety of N-methyl-2-pyrrolidone (NMP) in the formulation of Nuflor® injectable solution in cattle. FOI Summary
May 15, 2018 NADA 141-501 Boehringer Ingelheim Vetmedica, Inc. Semintra® Cats For the control of systemic hypertension in cats. FOI Summary
May 4, 2018 NADA 141-481 Kindred Biosciences, Inc. Mirataz™ Cats For the management of weight loss in cats. FOI Summary
April 25, 2018 NADA 141-454 AquaBounty Technologies, Inc. AquAdvantage Salmon Atlantic Salmon This supplement provides for an additional grow-out facility in Indiana for AquAdvantage Salmon.

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FONSI

March 26, 2018 NADA 141-491 Zoetis Inc. Coban™ and LINCOMIX® Broiler chickens As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. FOI Summary
March 8, 2018 NADA 141-492 Merial, Inc. Centragard™ Cats For the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of roundworms (adult and fourth stage larval Toxocara cati), hookworms (adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma braziliense), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis), in cats and kittens 7 weeks of age and older and 1.8 lbs or greater. FOI Summary
March 5, 2018 NADA 141-489 Zoetis Inc. Zoamix® and LINCOMIX® Broiler chickens For the prevention and control of coccidiosis, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. FOI Summary
March 2, 2018 NADA 141-484 Zoetis Inc. Bio-Cox® and LINCOMIX® Broiler chickens For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broiler chickens. FOI Summary
06.11.2018 04:04:48
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