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CVM FY12 Annual Report Apendix C

FY12 Significant Drug Approvals

For the purpose of New Animal Drugs, the term “Significant Approvals” means the approval of an original or supplemental New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA) that required substantial review of safety or effectiveness data (including bioequivalence studies) by CVM and provides for a new chemical entity, a new animal drug product or any of a variety of changes to existing approved NADAs or ANADAs, including additions to the indication section of the label of a new target species, a new significant class of target animals, a new disease indication, a new route of administration, a new tolerance or withdrawal period.

Original Generic

GENTAMICIN (gentamicin sulfate, betamethasone valerate) TOPICAL SPRAY

This original ANADA provided for the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

GENTAMED (gentamicin sulfate) SOLUBLE POWDER

This original ANADA provided for the control and treatment of colibacillosis in weanling swine caused by strains of E .coli sensitive to gentamicin, and for the control and treatment of swine dysentery associated with Treponema hyodysenteriae.

LOVET 100 (tylosin phosphate)

This original ANADA provided for:1) use in beef cattle for reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; 2) use in chickens for increased rate of weight gain and improved feed efficiency; 3) use in laying chickens for improved feed efficiency; 4) use in broilers and replacement chickens to aid in the control of chronic respiratory disease associated with Mycoplasma gallisepticum; 5) use in swine for increased rate of weight gain and improved feed efficiency, for maintaining weight gains and feed efficiency in the presence of atrophic rhinitis, for control of swine dysentery associated with Brachyspira hyodysenteriae, for the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin tartrate in drinking water, and for control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.

CEFTIOFUR (ceftiofur sodium) INJECTION STERILE POWDER

This original ANADA provided for the treatment of bovine respiratory disease, sheep respiratory disease, caprine respiratory disease, respiratory infections in horses associated with S. zooepidemicus, treatment/control swine bacterial respiratory disease, treatment of canine urinary tract infections assoc. with E. coliand P. mirabilis, control of early mortality assoc. with E. coli in day-old turkey poults and chicks.

ALTRESYN (altrenogest) 0 22% SOLUTION

This original ANADA provided for the suppression of estrus in mares .

SPARMECTIN PLUS CLORSULON (ivermectin and clorsulon) Injection

This original ANADA provided for the treatment and control of internal parasites, including adult liver flukes, and external parasites in cattle.

AMPROMED (amprolium) 9 6% ORAL SOLUTION

This original ANADA provided for an aid in treatment and prevention of coccidiosis caused by Eimeria bovis and E. zuernii in calves.

DEXAMETHASONE (dexamethasone) SOLUTION This original ANADA provided for the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses.

New Combination

EASOTIC (hydrocortisone aceponate, miconazole nitrate, gentamicin sulfate)otic suspension

This supplemental NADA provided for the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).

INTERCEPTOR SPECTRUM (milbemycin oxime/praziquantel) CHEWABLES

This supplemental NADA provided for the prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of adult roundworm (Toxocara canis and Toxascaris leonina), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, and Echinococcus granulosus) infections in dogs and puppies two pounds of body weight or greater and six weeks of age or older.

PULMOTIL 90 (tilmicosin phosphate) and RUMENSIN 90 (monensin) ADAA Combination of Type A Medicated Articles to manufacture Type B and C medicated feeds

This original NADA provided for:1) improved feed efficiency; 2) prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii; and 3) control of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where active BRD has been diagnosed in at least 10% of the animals in the group.It is the first ADAA combo with a VFD drug.

New Indication

DERAMAXX (deracoxib)

This supplemental NADA added a new indication for the control of postoperative pain and inflammation associated with dental surgery in dogs at a dose of 0.45-0.91 mg/lb (1-2 mg/kg) administered orally once daily for 3 days.

KINAVET CA-1 (masitinib mesylate)

This supplemental conditional approval modified the conditionally approved indication to remove dogs with recurrent (post-surgery) mast cell tumors from the indication. With this supplement, the original conditionally approved indication “ For the treatment of recurrent (post-surgery) or nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids” was changed to “For the treatment of nonresectable Grade II or III cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids”.

ZACTRAN (gamithromycin)

This supplemental NADA added a new indication for the treatment of bovine respiratory disease (BRD) associated with Mycoplasma bovis in beef and non-lactating dairy cattle.

EXCEDE (ceftiofur crystalline free acid) STERILE SUSPENSION

This supplemental NADA added a new indication for the treatment of acute metritis (0 to 10 days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle; and provide modified injection techniques for the base of the ear route of administration.

TYLOMED-WS (tylosin tartrate) SOLUBLE POWDER

This supplemental ANADA added new indications for the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate Type A Medicated Article in feed and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate Type A Medicated Article in feed. This claim is no longer protected under marketing exclusivity for the reference-listed new animal drug.

TYLOVET (tylosin tartrate) SOLUBLE

This supplemental ANADA added new indications for the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate Type A Medicated Article in feed and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate Type A Medicated Article in feed. This claim is no longer protected under marketing exclusivity for the reference-listed new animal drug.

CERENIA (maropitant citrate)

This supplemental NADA added to the indication “for use in dogs 8 weeks and older” for the prevention and treatment of acute vomiting in dogs.

BAYTRIL (enrofloxacin) 100 INJECTABLE SOLUTION

This supplemental NADA added a new indication for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

AQUAFLOR (florfenicol) Type A Medicated Article

This supplemental NADA provided for:1) an increase in the maximum florfenicol dose for the existing enteric septicemia indication for catfish, 2) added an indication for the control of mortality due to streptococcal septicemia associated with Streptococcus iniae in freshwater-reared warm-water finfish, and 3) added an indication for the control of mortality due to columnaris disease associated with Flavobacterium columnare in freshwater-reared finfish. This approval is the first transition of a conditionally-approved indication to a fully-approved product. It is also the result of cooperation between the pharmaceutical company, Intervet, Inc., and public sector researchers.

BIMECTIN (ivermectin) Pour-On

This supplemental ANADA updated the persistent activity statement to be consistent with the RLNAD as follows: “…has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment; Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.”

New Dosage

DANOFLOXACIN MESYLATE

This supplemental NADA added an additional dosage regimen for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica and Pasteurella multocida in beef cattle at a single dose of 8 mg danofloxacin/kg body weight (BW ).

MONTEBAN (narasin) TYPE A MEDICATED ARTICLE

This supplemental NADA increased the upper dosage range from 72 to 90 G/Ton to Feed for the prevention of coccidiosis in broiler chickens, caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.

New Formulation

DENAGARD (tiamulin hydrogen fumarate (THF)) TYPE A MEDICATED ARTICLE

This supplemental NADA provided for:1) a revised formulation of DENAGARD (tiamulin hydrogen fumarate) Type A Medicated Article containing 363 .2 Grams of tiamulin hydrogen fumarate per pound 2) a marketable Type B Medicated Swine Feed formulation containing 10 grams of tiamulin hydrogen fumarate per pound, and 3) the voluntary withdrawal of approval of DENAGARD 5, 10, and Premix Type A Medicated Articles containing 5, 10, and 113 .4 grams of tiamulin hydrogen fumarate per pound.

New Species/Class

LINCOMIX (lincomycin hydrochloride) SOLUBLE POWDER

This supplemental NADA added a new species and indication for the control of American foulbrood (Paenibacillus larvae) in honey bees.

New Chemical Entity

ZUPREVO (tildipirosin) 18% INJECTABLE SOLUTION

This original NADA approved the use of tildipirosin in cattle for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle, and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

RILEXINE (cephalexin monohydrate) CHEWABLE TABLETS

This original NADA will provide for the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.

ALFAXAN (alfaxalone) INTRAVENOUS INJECTABLE

This original NADA will provide for the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic in cats and dogs.

RECUVYRA (fentanyl) TRANSDERMAL SOLUTION

This original NADA will provide for the control of postoperative pain associated with surgical procedures in dogs.

AIVLOSIN (tylvalosin tartrate) WATER SOLUBLE GRANULES

This original NADA provided for the use of tylvalosin in the drinking water of swine the control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE.

SKYSIS (narasin)

This original NADA provided for: 1) 13 .6 to 27 .2 g/ton for increased rate of weight gain in growing-finishing swine when fed for at least 4 weeks; and 2) 18 .1 to 27 .2 g/ton for increased rate of weight gain and improved feed efficiency in growing-finishing swine when fed for at least 4 weeks.

OVUGEL (triptorelin)

This original NADA provided for the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.

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Page Last Updated: 07/23/2014
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