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FDA Approves New Label Indications For Bayer HealthCare (BAY)'s Advantage Multi® (Imidacloprid + Moxidectin) In The U.S.


12/20/2013 6:45:42 AM

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FDA approves new label indications for Bayer's Advantage Multi® (imidacloprid + moxidectin) in the U.S.

SHAWNEE, Kan.
, Dec. 20, 2013 /PRNewswire/ -- Bayer HealthCare LLC Animal Health division announced today that the U.S. Food and Drug Administration (FDA) has approved Advantage Multi® for Dogs for the treatment of circulating microfilaria, the first life stage of heartworm, making it the only FDA-approved product labeled for microfilaria treatment. According to the American Heartworm Society, there are conservatively 1 million cases of heartworm disease diagnosed in dogs every year.[1] Heartworm disease most commonly results in abnormal functioning of the lungs and heart, but can affect many other organs as well.[2] Advantage Multi® for Dogs was also approved by the FDA for the treatment and control of sarcoptic mange, which can result in intense itching in dogs and, in turn, cause hair loss, reddened skin, body sores and scabs.[3]

Heartworm prevention and flea kill now available for ferrets
Bayer also announced that the FDA has approved the use of Advantage Multi® for Cats (0.4 mL size only) to prevent heartworm disease, kill adult fleas and treat flea infestations in ferrets, making it the first-ever heartworm and flea product labeled for use on ferrets. According to the American Heartworm Society (AHS), ferrets are highly susceptible to heartworm infections and can suffer the effects of heartworm disease, similar to dogs and cats.[4] Additionally, ferrets can become infested with the same fleas that feed on dogs and cats, so it is also important to protect them from this parasite.

MUMS (Minor Use and Minor Species) designation by the FDA for this intended use of Advantage Multi® for Cats facilitated the approval of these first-ever ferret claims.

"The new indication for Bayer's Advantage Multi® for Dogs as the first treatment for heartworm microfilaria is a tremendous advancement in the animal health industry that will aid veterinarians' efforts to keep dogs healthy and reduce the heartworm infection pool," said Robert Zolynas, DVM, MBA, vice president, research and development at Bayer HealthCare Animal Health. "Bayer's commitment to finding solutions to keep animals healthy is further demonstrated by the approved indications for Advantage Multi® for Cats as the first heartworm and flea product for ferrets in the U.S. This is particularly important for veterinarians that treat the nearly 750,000 ferrets in the U.S."[5]

Prior to receiving these expanded indications:

  • Advantage Multi® for Dogs was approved for monthly, year-round topical application on dogs to prevent heartworm disease, kill adult fleas and treat flea infestations, and treat and control roundworms, hookworms and whipworms.
  • Advantage Multi® for Cats was approved for monthly, year-round topical application on cats to prevent heartworm disease, kill adult fleas and treat flea infestations, treat and control ear mites, and treat and control roundworms and hookworms.

Both Advantage Multi® for Dogs and Advantage Multi® for Cats are prescription-only products available from a licensed veterinarian or veterinary pharmacy.

About Advantage Multi® for Dogs
For more information on Advantage Multi® for Dogs, visit http://www.bayerdvm.com/show.aspx/productdetail/advantage-multi-for-dogs
Product Label
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. WARNING: DO NOT ADMINISTER THIS PRODUCT ORALLY. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Children should not come in contact with the application site for two (2) hours after application. (See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information.) CONTRAINDICATIONS: Do not use this product on cats.

About Advantage Multi® for Cats
For more information on Advantage Multi® for Cats, visit
http://www.bayerdvm.com/show.aspx/productdetail/advantage-multi-for-cats
Product Label
CAUTION: Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian. WARNINGS: Do not use on sick, debilitated, or underweight cats (see ADVERSE REACTIONS). Do not use on sick or debilitated ferrets. PRECAUTIONS: Avoid oral ingestion. HUMAN WARNINGS: Children should not come in contact with the application site for 30 minutes after application.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 million (2012), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec. 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.

Contact:
Staci Gouveia, Tel. 913.268.2577
Email: staci.gouveia@bayer.com

Lauren Dorsch, Tel. 913.268.2747
Email: lauren.dorsch@bayer.com

Find more information about Bayer HealthCare Animal Health at
www.animalhealth.bayerhealthcare.com
Follow us on Twitter: @Bayer4animalsUS
Follow us on Facebook: https://www.facebook.com/healthcare.bayer

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

[1]Weyenberg, K. (2009). Team Up Against Heartworm. The Team, pg. 10-12.
[2]American Heartworm Society, Canine Heartworm Disease, http://www.heartwormsociety.org/pet-owner-resources/canine-heartworm.html. Accessed October 14, 2013.
[3]Parasitic Skin Disease. In: Miller, Griffin, Campbell, eds. (2013) Muller & Kirk's Small Animal Dermatology. 7th ed. St. Louis, Missouri; Elsevier Publishing; 315-317.
[4]Heartwormsociety.org, Can ferrets get heartworm disease?, http://www.heartwormsociety.org/pet-owner-resources/faqs.html#q39. Accessed October 14, 2013.
[5]
American Veterinary Medical Association, 2012 U.S. Pet Ownership & Demographics Sourcebook, https://www.avma.org/KB/Resources/Statistics/Pages/Market-research-statistics-US-pet-ownership.aspx. Accessed October 14, 2013.

SOURCE Bayer HealthCare Animal Health



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