Sunday, October 20, 2019

Sunday, October 20, 2019

FDA Update: recent animal drug approvals


Pexels.com

Federal law dictates that drug companies can’t manufacture and market medicines for animals unless they get the approval of the U.S. Food and Drug Administration.

That approval, which is laid out in the Federal Food, Drug and Cosmetic Act, can only be given if the company’s application meets three criteria, the FDA reports:

– The drug must be shown to be safe and useful to treat health problems in a designated species. And if the animal is used in food production, the resulting food products need to be proved safe for human consumption.

– The company has to demonstrate that its manufacturing process will ensure drug quality and purity.

– The labeling of the medication must be accurate and contain all the information needed for the product to be used safely.

---

Recent Approvals of Animal Medications

DateApplication NumberSponsorProduct NameSpeciesIndications for Use/Effect of the Supplement
Sept. 20ANADA 200-642Huvepharma EOODMonovet® and Tylovet®Cattle fed in confinement for slaughterFor improved feed efficiency and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter. For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter.
Sept. 20ANADA 200-643Huvepharma EOODMonovet® and Tylan™Cattle fed in confinement for slaughterFor improved feed efficiency and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter. For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter.
Sept. 20ANADA 200-644Huvepharma EOODOptaflexx™and Monovet® and Tylovet®Cattle fed in confinement for slaughterFor increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.

Sept. 20ANADA 200-645Huvepharma EOODActogain™ and Monovet® and Tylovet™Cattle fed in confinement for slaughterFor increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.

Sept. 20ANADA 200-646Huvepharma EOODOptaflexx™ and Monovet® and Tylan™Cattle fed in confinement for slaughterFor increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.

Sept. 20ANADA 200-647Huvepharma EOODActogain™ and Monovet® and Tylan™Cattle fed in confinement for slaughterFor increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.

For increased rate of weight gain, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.

Sept. 20ANADA 200-648Huvepharma EOODOptaflexx™ and Monovet® and Tylovet® and MGA®Heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
Sept. 20ANADA 200-649Huvepharma EOODActogain™ and Monovet® and Tylovet® and MGA®Heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
Sept. 20ANADA 200-650Huvepharma EOODOptaflexx™ and Monovet® and Tylan™ and MGA®Heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
Sept. 20ANADA 200-651Huvepharma EOODActogain™ and Monovet® and Tylan™ and MGA®Heifers fed in confinement for slaughterFor increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency and suppression of estrus (heat).
Sept. 3NADA 141-494Elanco US Inc.Credelio™DogsThis supplement provides for the addition of the indication for the prevention of flea

infestations (Ctenocephalides felis) for one month in dogs and puppies 8 weeks of age and

older, and weighing 4.4 pounds or greater.

Aug. 27NADA 141-465Elanco US Inc.Inteprity™ and Coban™Broiler chickensThis supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days of age as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.
Aug. 27NADA 141-467Elanco US Inc.Inteprity™ and Monteban™Broiler chickensThis supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days of age as follows: To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.
Aug. 27NADA 141-495Elanco US Inc.Inteprity™ and Bio-Cox®Broiler chickensThis supplement provides for a change in the broiler chicken age restriction caution statement from 10 days to 18 days as follows: To assure reasonable antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age.
July 26NADA 141-255Syndel USA35% PEROX-AID®Freshwater-reared finfishThis supplement provides for the addition of the following indications: For the control of mortality in freshwater-reared coldwater finfish, fingerling and adult freshwater-reared coolwater finfish, and fingerling and adult freshwater-reared warmwater finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae. For the treatment and control of Gyrodactylusspp. in freshwater-reared salmonids. For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare.
July 5NADA 113-645Intervet, Inc.Estrumate®Lactating dairy cowsThis supplement provides for addition of the indication ‘For use with Fertagyl® (gonadorelin) to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows.’
July 1NADA 141-519Zoetis Inc.ProHeart® 12Dogs 1 year of age and olderFor use in dogs 12 months of age and older for the prevention of heartworm disease caused by Dirofilaria immitisfor 12 months. For the treatment of existing larval and adult hookworm (Ancylostoma caninum and Uncinaria stenocephala) infections.
July 1ANADA 200-639Huvepharma EOODMonovet® 90Cattle fed in confinement for slaughter, dairy cows, growing cattle on pasture or in dry lot (stocker and feeder and dairy and beef replacement heifers), mature reproducing beef cows, calves (excluding veal calves), and goatsCattle fed in confinement for slaughter: for improved feed efficiency; for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Dairy cows: for increased milk production efficiency (production of marketable solids-corrected milk per unit of feed intake). Growing cattle on pasture or in dry lot (stocker and feeder and dairy and beef replacement heifers): for increased rate of weight gain; for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Mature reproducing beef cows: for improved feed efficiency when receiving supplemental feed; for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Calves (excluding veal calves): for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Goats: for the prevention of coccidiosis caused by Eimeria crandallis, Eimeria christenseni, and Eimeria nina kohl yakimova in goats maintained in confinement.
May 30ANADA 200-537Bimeda Animal Health Ltd.OxyMed™ LASwine, beef cattle, dairy cattle, and calves including preruminating (veal) calvesCattle: For the treatment of pneumonia and shipping fever complex associated with Pasteurellaspp. and Haemophilusspp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. Swine: For the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, OxyMed™ LA is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
May 21NADA 141-514Elanco US Inc.Experior™ and Rumensin™Beef steers and heifers fed in confinement for slaughter1) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed. 2) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight and improved feed efficiency in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.
May 21NADA 141-512Elanco US Inc.Experior™ and Rumensin™ and Tylan™Beef steers and heifers fed in confinement for slaughter1) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

2) For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, improved feed efficiency, and reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

May 16ANADA 200-598Bimeda Animal Health LimitedEnroMed™ 100Cattle (beef and non-lactating dairy) and

swine

Cattle-Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Cattle-Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae, and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

May 7ANADA 200-633Pharmgate Inc.Denagard® and Deracin®SwineFor control of swine dysentery associated with Brachyspira (formerly Serpulinaor Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline.
May 6NADA 141-288Zoetis Inc.EXCENEL® RTU EZSwineThis supplement provides for an increase in the maximum injection site volume in swine from 5 mL to 15 mL. The larger maximum injection site volume will reduce the number of injections needed in larger pigs.
April 11NADA 140-989Syndel USAPARASITE-SFreshwater-reared finfishThis supplement provides for the addition of the following indication: For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae.
Source: U.S. Food and Drug Administration

Organizations in this Story

U.S. Food and Drug Administration (FDA)

More News

FDA Reporter