Animal & Veterinary
CVM has published in the Federal Register notice of the approval of these Abbreviated New Animal Drug Applications (ANADA)
FDA Veterinarian Newsletter September/October 2004 Volume XIX, No V
- Prescription use of Oxytocin Injectable Solution, filed by Cross Vetpharm Group, Ltd. (ANADA 200-328). The product is for use in ewes, sows, cows and horses. It is indicated to be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery, it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state. Cross Vetpharm Group’s Oxytocin Injection is approved as a generic copy of Phoenix Scientific Inc.’s PVL Oxytocin Injectable approved under NADA 124-241. Notice of approval was published July 9, 2004.
- SPECMED Scour-Chek (Spectinomycin dihydrochloride pentahydrate) filed by Cross Vetpharm Group. Ltd. (ANADA 200-364). The product is for the oral use in pigs under 4 weeks of age for the treatment and control of infectious bacterial enteritis (white scours) associated with Escherichia coli. Cross Vetpharm Group’s SPECMED Scour-Chek is approved as a generic copy of Phoenix Scientific, Inc.’s SPECTAM Scour Halt, approved under NADA 033-157. Notice of approval was published August 30, 2004.
- PENNCHLOR and BMD (Chlortetracycline Type A and Bacitracin methylene disalicylate medicated articles), filed by Pennfield Oil Co. (ANADA 200-358). The ANADA provides for the use of single-ingredient Type A medicated articles to make two-way combination drug Type B and Type C medicated feeds for swine for increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline hydrochloride. Pennfield Oil Co.’s product is approved as a generic copy of Alpharma, Inc.’s BMD and ChlorMax NADA, approved under 141-059. Notice of approval was published August 18, 2004.
- VETRO-GEN Veterinary Ophthalmic Ointment (Gentamicin sulfate), filed by Altana, Inc. (ANADA 200-273). The product is for use on dogs and cats for topical treatment of conjunctivitis caused by susceptible bacteria. Altana’s product is approved as a generic copy of Schering-Plough Animal Health’s GENTOCIN Ophthalmic Ointment approved under NADA 98-989. Notice of approval was published August 5, 2004.
- Ivermectin Chewable Tablets, filed by Phoenix Scientific, Inc., (ANADA 200-297). The ANADA provides for the veterinary prescription use of chewable ivermectin tablets in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for 1 month (30 days) after infection. Phoenix Scientific, Inc.’s Ivermectin Chewable Tablets for Dogs are approved as a generic copy of Merial Ltd.’s HEARTGARD Chewables, approved under NADA 140-886. Notice of approval was published July 22, 2004.
- HAN-PEN (Penicillin G Potassium) Soluble Powder, filed by G. C. Hanford Manufacturing Co. (ANADA 200-372). The product is for use in the drinking water of turkeys for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae. G. C. Hanford Manufacturing Co.’s product is approved as a generic copy of Fort Dodge Animal Health’s Penicillin G Potassium, USP, approved under NADA 55-060. Notice of approval was published July 9, 2004.
- ESTROPLAN (Cloprostenol sodium) Injection filed by Parnell Laboratories (Aust) Pty. Ltd. (ANADA 200-310). The product is for the use by veterinary prescription for manipulation of the estrous cycle of cattle. Parnell Laboratories (Aust) Pty. Ltd.’s ESTROPLAN Injection is approved as a generic copy of Schering-Plough Animal Health Corp.’s -ESTRUMATE, approved under NADA 113-645. Notice of approval was published on July 7, 2004.