Animal & Veterinary
Approvals for New Animal Drugs for August and September 2006
FDA Veterinarian Newsletter 2006 Volume XVII, No IV
CVM has published in the Federal Register notice of the approval of this New Animal Drug Application (NADA)
ZILMAX (zilpaterol hydrochloride 4.8%) Type A medicated article (NADA 141-258), filed by Intervet Inc. The NADA provides for the use of this Type A medicated article to formulate Type B (liquid and dry) and Type C medicated cattle feeds used for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed. Notice of approval was published September 8, 2006.
CVM has published in the Federal Register notice of the approval of these Abbreviated New Animal Drug Applications (ANADA)
NEOMIX 325 (neomycin sulfate) Soluble Powder (ANADA 200-378), filed by Sparhawk Laboratories, Inc. The ANADA provides for the use of neomycin soluble powder in cattle, swine, sheep, goats, and turkeys for the treatment and control of bacterial enteritis. Based on the formulation characteristics of the generic product, Sparhawk Laboratories, Inc., was granted a waiver from the requirement of an in vivo bioequivalence study for the generic product, Neomycin Sulfate 325 (neomycin sulfate). The generic product is administered as a soluble powder, contains the same active ingredients in the same concentration and dosage form as the pioneer product, and contains no inactive ingredients that may significantly affect the absorption of the active ingredient. The pioneer product, NEOMIX 325 (neomycin sulfate) Soluble Powder was the subject of NADA 011-315, sponsored by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. Notice of approval was published September 28, 2006.
AMPROLIUM 9.6% Oral Solution (ANADA 200-389), filed by IVX Animal Health, Inc. The ANADA provides for the use of Amprolium 9.6% Oral Solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves. IVX Animal Health’s Amprolium 9.6% Oral Solution is approved as a generic copy of Merial Limited’s CORID (amprolium) 9.6% Solution, approved under NADA 13-149. Notice of approval was published September 27, 2006.
LINCOMED 100 and LINCOMED 300 (lincomycin hydrochloride) (ANADA 200-368), filed by Cross Vetpharm Group Ltd. The ANADA provides that both products are approved as generic copies of LINCOMIX 100 Injectable and LINCOMIX 300 Injectable, sponsored by Pharmacia & Upjohn Co., a division of Pfizer, Inc., under NADA 034-025. Lincomycin hydrochloride is used in swine for the treatment of infectious arthritis caused by staphylococci, streptococci, Erysipelothrix, and Mycoplasma spp., and for the treatment of mycoplasma pneumonia. Notice of approval was published on September 1, 2006.
GENTAMICIN SULFATE SOLUTION filed by Sparhawk Laboratories (ANADA 200-395). The ANADA provides for the use of the product for the control of bacterial infections of the uterus (metritis) and as an aid in improving conception in mares with uterine infections cause by bacteria sensitive to gentamicin. The sponsor’s gentamicin sulfate solution is approved as a generic copy of Schering-Plough Animal Health Corporation’s Gentocin (gentamicin sulfate) Solution Veterinary, approved under NADA 46-724. Notice of approval was published August 31, 2006.
CVM has published in the Federal Register notice of the approval of these Supplemental New Animal Drug Applications (NADA)
DRAXXIN (tulathromycin) injectable solution filed by Pfizer, Inc. (NADA 141-244). The supplemental NADA provides for the addition of a pathogen, Mycoplasma bovis, to the indication for use of tulathromycin solution in cattle, by subcutaneous injection for the treatment of bovine respiratory disease. This supplemental approval qualifies for 3 years of marketing exclusivity, beginning August 18, 2006. Notice of approval was published September 29, 2006.
BOVATEC 91 (lasalocid) Type A medicated article (NADA 141-171), filed by Purina Mills, Inc. The supplemental NADA provides for the use of a lasalocid Type A medicated article containing 20 percent lasalocid activity per pound for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Notice of approval was published September 26, 2006.
AUREOMYCIN 90 Granular (chlortetracycline) Type A medicated article to formulate a free-choice loose mineral Type C medicated feed for beef and nonlactating dairy cattle (NADA 48-761), filed by Alpharma Inc. The supplemental NADA provides for the use of chlortetracycline as an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. Notice of approval was published September 13, 2006.
TERRAMYCIN 100MR (oxytetracycline dihydrate) Type A medicated article (NADA 95-143), filed by Phibro Animal Health. The supplemental NADA provides for the revision of labeling of the product, which is approved for treating various bacterial diseases of livestock, with the current genus for the causative bacteria for American foulbrood of honeybees. Notice of approval was published September 8, 2006.
CORID (amprolium) Type A Medicated Article 25% (NADA 12-350), filed by Merial Ltd. The supplemental NADA provides for formulation of Type C medicated calf feeds used for the prevention and treatment of coccidiosis caused by Eimeria bovis and E. zurnii at a broader range of concentrations. Specifically, it was determined that the original feeding range of amprolium of 0.05 to 1.25 percent was too narrow to encompass all calves at the range of body weights and different possible dry matter intake levels. Therefore, the minimum allowable concentration of amprolium in Type C medicated feed has been lowered from 0.05 percent to 0.0125 percent amprolium making the feeding range 0.0125 to 1.25 percent (113.5 g/ton to 11,350 g/ton). Notice of approval was published September 6, 2006.
TERRAMYCIN (oxytetracycline dihydrate) for Fish Type A medicated article filed by Phibro Animal Health (NADA 38-439). The supplemental NADA provides for the approval of the dihydrate salt of oxytetracycline, a change of oxytetracycline concentration in the Type A medicated article, and the addition of an indication for the control of gaffkemia in lobsters. Notice of approval was published August 8, 2006.
CVM has published in the Federal Register notice of the approval of these Supplemental Abbreviated New Animal Drug Applications (ANADA)
TRIPLEMAX (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP ointment) (ANADA 200-287), filed by IVX Animal Health, Inc. The supplemental ANADA provides for a new container size, a 40-gram dropper bottle, to administer the drug, which is approved for the treatment of acute and chronic canine otitis externa. Notice of approval of the supplemental ANADA was published September 28, 2006.
NOVOX (carprofen) caplets (ANADA 200-366), filed by IMPAX Laboratories, Inc. The supplemental ANADA provides for the use of Novox caplets for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. Notice of approval was published September 1, 2006.