Label: EXPERIOR 10- lubabegron granule

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated January 31, 2024

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  • Experior™10TM

    (lubabegron Type A medicated article)

    For Use in Feeds for Beef Steers and Heifers Fed in Confinement for Slaughter

  • Important:

    For further manufacturing only. Experior 10 must be thoroughly mixed into feeds before use. Follow label directions.

  • Active Drug Ingredient:

    Lubabegron (as lubabegron fumarate) - 10 g per kg (4.54 g per lb)

  • Inert Ingredients:

    Corn cob grits, mineral oil, citric acid.

  • Indications for Use:

    For reduction of ammonia gas emissions per pound of live weight and hot carcass weight in beef steers and heifers fed in confinement for slaughter during the last 14 to 91 days on feed.

    Effectiveness has not been demonstrated when fed for less than 14 days.

    Ammonia gas emissions were measured for individual animals or small groups of animals held in environmentally controlled facilities. Based on existing information, reliable predictions of the reduction of ammonia gas emissions cannot be made on a herd, farm, or larger scale.

    Increased rate of weight gain, improved feed efficiency, and increased carcass leanness have not been demonstrated with this product.

  • Mixing Directions (Dry Type B Medicated Feeds):

    Thoroughly mix Experior 10 Type A medicated article in a ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B medicated feed (maximum 720 g/ton). The following table gives examples of how some Type B medicated feed concentrations can be prepared:

    a Experior 10 contains 4.54 grams of lubabegron per pound
    b Based on 90% Dry Matter Basis

    Pounds of Experior 10 Type Aa
    To Add Per Ton To Make
    a Type B Medicated Feed

    Resulting lubabegron Concentration in
    Type B Medicated Feedb

    grams/ton

    9.9

    45

    77.1

    350

    158.6

    720

  • Mixing Directions (Liquid Type B Medicated Feeds):

    Thoroughly mix Experior 10 Type A medicated article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (15.5 to 185 g/ton). If mixing less than 5 pounds of Type A medicated article per ton to make a Type B liquid medicated feed, you must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 10 Type A medicated article in a convenient quantity of feed ingredients or diluents, and then mix the pre-blend into the remaining feed ingredients or diluents to make a Type B liquid medicated feed.

    Formulate medicated feed to a pH of 4 to 9 and dry matter content of 60% to 75%. Liquid Type B Medicated Feeds containing Experior stored in recirculation tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving no less than 1% of the tank contents per minute from the bottom to the top of the tank. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

    The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

    a Experior 10 contains 4.54 g lubabegron per pound

    Pounds of Experior 10 Type Aa
    To Add Per Ton to Make a
    Liquid Type B Medicated Feed

    Resulting lubabegron Concentration in
    Liquid Type B Medicated Feed

    grams/ton

    3.4

    15.5

    22.0

    100

    40.7

    185

  • Mixing Directions (Dry Type C Medicated Complete Feeds):

    Thoroughly mix Experior 10 Type A medicated article in a ton of complete cattle feed according to the table below to obtain the proper concentration in the Type C medicated feed. You must prepare an intermediate pre-blend by thoroughly mixing the required amount of Experior 10 Type A medicated article in a convenient quantity of feed ingredients, and then add the pre-blend to the remaining feed ingredients to make a complete feed.

    a Experior 10 contains 4.54 grams of lubabegron per pound
    b Based on 90% Dry Matter Basis
    c Rounded value

    Pounds of Experior 10 Type Aa
    To Add Per Ton To Make a Type C Medicated Feed

    Resulting lubabegron Concentration (g/ton)
    in Type C Medicated Feedb

    0.28c

    1.25

    0.55

    2.50

    1.00

    4.54

  • Feeding Directions:

    Feed 1.25 to 4.54 g/ton (1.39 to 5 ppm) of complete feed (90% dry matter basis) to provide 13-90 mg lubabegron/head/day continuously to beef steers and heifers fed in confinement for slaughter as the sole ration during the last 14 to 91 days on feed.

  • Caution:

    Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed containing Experior 10. A decrease in dry matter intake may be noticed in some animals.

  • Warnings:

    No withdrawal period is required when used according to labeling.

  • User Safety Warning:

    The active ingredient in Experior 10, lubabegron, is a beta-adrenergic agonist/antagonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for human use. Keep out of reach of children. When mixing and handling Experior 10, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water; if wearing contact lenses, rinse eyes first, then remove contact lenses and continue to rinse for 5-20 minutes. If irritation persists, seek medical attention. The safety data sheet contains more detailed occupational safety information. To report adverse drug events, access medical information, or obtain additional product information, call Elanco US Inc. at 1-800-428-4441. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

    Lot No:

    Expiry Date:

  • Storage Information:

    Store at or below 25°C (77°F). Excursions permitted to 30°C (86°F).

    Not to be used after the date printed on the bag.

    Restricted Drug (California) – Use Only as Directed

    Approved by FDA under NADA #141-508

    Manufactured For:

    Elanco US Inc.

    2500 Innovation Way

    Greenfield, IN 46140, U.S.A.

    Experior, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    © 2021 Elanco or its affiliates

    Net Weight 10 kg
    (22.04 lb)

    TAKE TIME

    Figure

    OBSERVE LABEL
    DIRECTIONS

    YL103063X

  • Principal Display Panel – Experior 10kg Bag Label

    Elanco™

    Experior™10TM

    (lubabegron Type A
    medicated article)

    Principal Display Panel - Experior 10kg Bag Label
  • INGREDIENTS AND APPEARANCE
    EXPERIOR 10 
    lubabegron granule
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:58198-1567
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lubabegron (UNII: 8501207BZX) (Lubabegron - UNII:8501207BZX) Lubabegron10 g  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-1567-110 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14150811/06/2018
    Labeler - Elanco US Inc. (966985624)