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U.S. Department of Health and Human Services

Animal & Veterinary

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Abbreviated New Animal Drug Approvals - November/Decmeber 2003

FDA Veterinarian Newsletter November/December 2003 Volume XVIII, No 6

Company
Generic and (Brand) Names
Indications
Routes/Remarks 

Veterinary Laboratories, Inc.
(ANADA 200-315)
Lincomycin hydrochloride
Swine. For the treatment of infectious arthritis and mycoplasma pneumonia.
SUBCUTANEOUS OR INTRAMUSCULAR-The ANADA provides for the use of Lincomycin injectable solution in swine for the treatment of infectious arthritis and mycoplasma pneumonia. Additional action is taken because the concentration of lincomycin solution approved under an ANADA published in the FR on May 14, 2002, was unspecified. Veterinary Laboratories, Inc's Lincomycin injection is a generic copy of Pharmacia & Upjohn Co.'s Lincomix approved under NADA 034-025.
Federal Register:08/28/03

Pennfield Oil Co.
(ANADA 200-357)
Salinomycin, Chlortetracycline (Pennchlor)
Broiler chickens.
MEDICATED FEED-The NADA provides for the use of single-ingredient Type A medicated articles containing salinomycin and chlortetracycline to make two-way combination drug Type C medicated feeds for broiler chickens. Pennfield Oil Co.'s ANADA 200-357 is a generic copy of Alpharma, Inc.'s NADA 140-859.
Federal Register 09/19/03

Agri Laboratories, Ltd.
(ANADA 200-128)
Oxytetracycline (Agrimycin® 200)
Cattle, Swine. For the treatment of various bacterial diseases.
SUBCUTANEOUS OR INTRAMUSCULAR-The ANADA provides for the use of Agrimycin 200. Agri Laboratories Agrimycin 200 is a generic copy of Pfizer's Liquamycin LA-200,approved under NADA 113-232.
Federal Register:09/19/03

First Priority, Inc.
(ANADA 200-353)
Pyrantel pamoate (Primex Equine) RX
Horses and ponies. For removal and control of various internal parasites.
ORAL-The ANADA provides for Primex Equine Anthelmintic Suspension for oral use in horses and ponies for the removal and control of various internal parasites. First Priority's Primex is a generic copy of Pfizer, Inc.'s Strongid T, approved under NADA 91-739.
Federal Register 09/19/03

Altana, Inc.
(ANADA 200-330)
Nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide (Animax Cream) RX
Dogs and Cats. For dermatologic use.
TOPICAL-The ANADA provides for use of Animax Cream Veterinary, a vanishing cream based ointment, for topical dermatologic use in dogs and cats. Altana, Inc.'s Animax Cream is a generic copy of Fort Dodge Animal Health's Panalog Cream, approved under NADA 96-676.
Federal Register 09/23/03

First Priority, Inc.
(ANADA 200-352)
Pyrantel pamoate (Primex Canine, Primex Canine-2X)
Dogs. For management of various internal parasites.
ORAL-The ANADA provides for oral use in dogs and puppies of two strengths of pyrantel pamoate suspension for the removal of large roundworms (Toxocara canis) and hookworms (Ancylostomacaninum). First Priority's PRIMEX CANINE and Primex Canine-2X are generic copies of Pfizer, Inc.'s RFD Suspension and Nemex-2 Suspension, approved under NADA 100-237.
Federal Register 09/29/03

First Priority, Inc.
(ANADA 200-304)
Copper Naphthenate (PritoxTM)
Horses and ponies. Used as an aid in treating thrush.
TOPICAL-The ANADA provides for topical use of copper naphthenate solution on horses and ponies as an aid in treating thrush caused by organisms susceptible to copper naphthenate. First Priority's Pritox is a generic copy of Fort Dodge Animal Health's Kopertox, approved under NADA 12-991.
Federal Register 09/29/03

Pennfield Oil Co.
(ANADA 200-354)
Monensin (Coban®), Chlortetracycline (PennchlorTM)
Broiler chickens.
MEDICATED FEED-The ANADA provides for the use of single ingredient Type A medicated articles containing monensin and chlortetracycline to make two-way combination drug Type C medicated feeds for broiler chickens. Pennfield Oil Co.'s ANADA 200-354 is a generic copy of Alpharma Inc.'s NADA 121-553 for combination use of Aureomycin (chlortetracycline) and Coban.
Federal Register 09/29/03

Heska Corp.
(ANADA 200-338)
Ivermectin/Pyrantel pamoate (Tri-Heart Plus) RX
Dogs. For treatment and control of certain gastrointestinal parasites.
ORAL-The ANADA provides for veterinary prescription use of Tri-Heart Plus Chewable Tablets for prevention and control of ascarids and hookworms in dogs. Heska Corp.'s Tri-Heart Plus is a generic copy of Merial's Heartgard Plus Chewables, approved under NADA 140-971.
Federal Register 09/29/03

Veterinary Laboratories, Inc.
(ANADA 200-324)
Dexamethasone RX
Cattle, Horses. For treatment of primary bovine ketosis and as an anti-inflammatory agent.
INTRAVENOUS OR INTRAMUSCULAR-The ANADA provides for use of Dexamethasone injection for the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses. Veterinary Laboratories, Inc.'s Dexamethasone is a generic copy of Schering-Plough Animal Health's Azium Solution 2 Mg., approved under NADA 012-559.
Federal Register 10/02/03

Phoenix Scientific, Inc.
(ANADA 200-265)
Praziquantel
Dogs. For the removal and control of certain cestode parasites.
ORAL-The ANADA provides for the use of Praziquantel Tablets for the removal and control of certain cestode parasites in dogs. Phoenix Scientific, Inc.'s Praziquantel is a generic copy of Bayer HealthCare LLC's Droncit, approved under NADA 111-798.
Federal Register 10/03/03