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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for July 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No III

CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Approvals (NADA)

  • CARBOCAINE-V (mepivacaine hydrochloride) Sterile Aqueous Solution (NADA 100-703), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for revised food safety labeling for mepivacaine injectable solution used in horses for local anesthesia. Notice of approval was published July 13, 2006.
  • SALIX (furosemide) Injection 5% (NADA 034-478), filed by Intervet, Inc. The supplemental NADA provides for the revision of a food safety warning on labeling of furosemide injectable solution for use in horses for the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute non-inflammatory tissue edema. Notice of approval was published July 13, 2006.
  • EXCEDE (ceftiofur crystalline free acid) Sterile Suspension (NADA 141-209), approved for veterinary prescription use by injection in cattle for respiratory disease, filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of ceftiofur crystalline free acid suspension via a new subcutaneous injection site in beef and nonlactating dairy cattle (subcutaneous injection in the posterior aspect of the ear where it attaches to the head at base of the ear), and for use in lactating dairy cattle by subcutaneous injection in the base of the ear for the treatment of respiratory disease. The supplement also provides for the establishment of a 13-day pre-slaughter withdrawal period in cattle. FDA is amending the regulations to revise the tolerance for residues of ceftiofur in bovine kidney to accommodate these new conditions of use. Notice of approval was published July 13, 2006.
  • NAXCEL (ceftiofur sodium) Sterile Powder for Injection (NADA 140-338), EXCENEL RTU (ceftiofur hydrochloride) Sterile Suspension (NADA 140-890), SPECTRAMAST LC (ceftiofur hydrochloride) Sterile Suspension (NADA 141-238), and SPECTRAMAST DC (ceftiofur hydrochloride) Sterile Suspension (NADA 141-239), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. NAXCEL and EXCENEL RTU are approved for veterinary prescription use in livestock by injection for the treatment or control of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. SPECTRAMAST LC and SPECTRAMAST DC are approved for veterinary prescription use by intramammary infusion in dairy cows for the treatment of bacterial mastitis. The four supplemental NADAs establish or revise preslaughter withdrawal periods in cattle injected with a solution made from ceftiofur sodium powder or with a suspension of ceftiofur hydrochloride, or receiving an intramammary infusion of ceftiofur hydrochloride consistent with the tolerance for residues of ceftiofur in bovine kidney, which was revised for EXCEDE (ceftiofur crystalline free acid) Sterile Suspension (NADA 141-209), which is described above. Notice of approval for these supplemental NADAs was published July 13, 2006.
  • HYLARTIN (sodium hyaluronate) Injection (NADA 112-048), filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for a revised food safety warning on the labeling of sodium hyaluronate approved for veterinary prescription use by intra-articular injection for the treatment of joint dysfunction in horses due to noninfectious synovitis associated with equine osteoarthritis. Notice of approval was published July 12, 2006.
  • THRUSH-XX (copper naphthenate) (NADA 100-616), filed by Farnam Companies, Inc. The supplemental NADA provides for a revised food safety warning on the labeling of copper naphthenate, a solution approved for topical use on horse and pony hooves as an aid in treating thrush. Notice of approval was published July 5, 2006.

CVM has published in the Federal Register notice of the approval of these Abbreviated New Animal Drug Approvals (ANADA)

  • Ivermectin Paste 1.87% (ANADA 200-390), filed by Med-Pharmex, Inc. The ANADA provides for oral use of ivermectin paste in horses for treatment and control of large strongyles, small strongyles, pinworms, roundworms (ascarids), hairworms, new threadworms, large-mouth stomach worms, and bots. Med-Pharmex’s Ivermectin Paste 1.87% is approved as a generic copy of Merial Ltd.’s EQVALAN Paste, approved under NADA 134-314. Notice of approval was published July 14, 2006.
  • HEIFERMAX 500 (melengestrol acetate) Liquid Premix, BOVATEC (lasalocid), and TYLAN (tylosin phosphate) single-ingredient Type A medicated articles (ANADA 200-430), filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, lasalocid, and tylosin to make dry and liquid, three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter. This ANADA is approved as a generic copy of NADA 138-992, sponsored by Pharmacia and Upjohn Co., a Division of Pfizer, Inc., for combination use of MGA 500 (melengestrol acetate) Liquid Premix, BOVATEC, and TYLAN in cattle feed. Notice of approval was published July 12, 2006.
  • VETRO-MAX (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP, ointment) (ANADA 200-283), filed by Altana, Inc. The ANADA provides for the veterinary prescription use of gentamicin sulfate, betamethasone valerate, clotrimazole ointment for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin. Altana, Inc.’s VETRO-MAX Otic Ointment is approved as a generic copy of Schering-Plough Animal Health Corp.’s OTOMAX Ointment approved under NADA 140-896. Notice of approval was published July 6, 2006.
  • Griseofulvin (griseofulvin) Powder Microsize (ANADA 200-391), filed by IVX Animal Health, Inc. The ANADA provides for veterinary prescription use of griseofulvin powder orally as a systemic antifungal agent in horses. IVX Animal Health’s Griseofulvin Powder Microsize, is approved as a generic copy of Schering-Plough Animal Health Corp.’s -FULVICIN-U/F (griseofulvin) Powder approved under NADA 039-792. Notice of approval was published July 5, 2006.
  • Oxytetracycline HCl (oxytetracycline hydrochloride) Soluble Powder (ANADA 200-305), filed by Vétoquinol NA, Inc. The ANADA provides for use of Oxytetracycline HCl Soluble Powder to prepare medicated drinking water for the treatment of various bacterial diseases of livestock. In chickens, it is used for the control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline; for control of chronic respiratory disease and air sac infections caused by Mycoplasma gallisepticum and Escherichia coli and fowl cholera caused by Pasteurella multocida susceptible to oxytetra-cycline. In turkeys, it is used for control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline and for control of infectious synovitis caused by Mycoplasma synoviae susceptible to oxytetracycline; in growing turkeys, it is used for control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to oxytetracycline; in swine, it is used for control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline; and in breeding swine, it is used for Leptospirosis (reducing the incidence of abortion) and shedding of leptospira caused by Leptospira pomona suspectible to oxytetracycline. -Vétoquinol NA, Inc.’s Oxytetracycline HCl Soluble Powder is approved as a generic copy of Alpharma, Inc.’s OXY-TET (oxytetracycline hydrochloride) Soluble approved under NADA 130-435. Notice of approval was published July 5, 2006.

CVM has published in the Federal Register notice of the approval of these Supplemental ANADAs

  • CLINSOL (clindamycin hydrochloride) Liquid (ANADA 200-291), filed by Virbac AH, Inc. The supplemental ANADA provides for an expanded dose range and revised wording of indications for the oral use of clindamycin hydrochloride liquid in dogs and cats for the treatment of certain bacterial diseases. Notice of approval was published July 13, 2006.
  • CLINITABS (clindamycin hydrochloride) tablets (ANADA 200-316), filed by Virbac AH, Inc. The supplemental ANADA provides for an expanded dose range and revised wording of indications for the oral use of clindamycin hydrochloride tablets in dogs for the treatment of certain bacterial diseases. Notice of approval was published July 12, 2006.
  • IVERSOL (ivermectin) Liquid for Horses (ANADA 200-292), filed by Med-Pharmex, Inc. The supplemental ANADA provides for revisions to label indications and to the food safety warning for ivermectin liquid administered by mouth or nasogastric tube to horses for treatment and control of various internal parasites or parasitic conditions. Notice of approval was published July 5, 2006.