Importance of FDA Approval

FDA Approval:
Know why it’s important. Know your choices.

Understanding the significance of FDA Approval is essential whether you are a veterinarian, trainer or owner. For a new veterinary drug to satisfy each stage of the FDA Approval process often takes years, and the stringent requirements provide the benchmark for veterinary drug safety and efficacy. Veterinarians can use and prescribe knowing they are providing care to the horse supported by appropriate clinical data. Non-approved alternatives do not come with the same level of testing.

Adequan Equine veterinarian giving horse injection
Adequan Equine fda requirements comparison

Key facts to know

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FDA Pioneer Drug
A pioneer drug is a brand name animal drug as submitted and approved through the FDA review process.1

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Medical devices
A medical device does not achieve its primary intended purposes through chemical action within or on the body of animals and is not dependent upon being metabolized for the achievement of its primary intended purposes. It is also not a generic form of an FDA-Approved drug. The key difference between an animal drug and an animal device is how the product works, because a drug relies on a chemical action occurring in or on the animal’s body and needs to be metabolized to work.2

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Compounded drugs
A compounded drug is any drug manipulated to produce a new dosage form drug. Legal compounding requires a valid veterinarian-client-patient relationship (VCPR). Use of compounded drugs should be limited to unique needs in specific animals and to those uses for which a response to therapy can be monitored, or those for which no other method or route of drug delivery is practical or available. It is illegal to compound a specific product when there is an approved drug form of that product except to make a different dosing form. However, the approved product must be used to make the compounded new dose form. Bulk compounding and sales is illegal. The prescribing veterinarian and owner should remember that compounded drugs are not subject to the FDA-Approval process for testing for safety, efficacy, stability, potency and consistency of manufacturing. Consistency from one batch to another, amount of the stated drug substance, and safety and efficacy for the intended use cannot be ensured.1

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Oral joint supplements
An oral joint supplement is loosely classified as a nutraceutical. The term “nutraceutical” combines the word “nutrient” (nourishing food or food component) with “pharmaceutical” (a medical drug) and describes a broad list of products sold under the premise of being a dietary supplement (i.e., a food) but for the expressed intent of treatment or prevention of disease. The variety of claims to aid in equine joint health are often unsupported. The potential difference between a feed and a nutraceutical is that a nutraceutical is unlikely to have an established nutritive value. Feeds are required to have nutritive value and are accountable, by labeling, for these values. Joint supplements fall in between food and drug and have marketing advantages over both because they are not required to list ingredients or nutrient profiles as required by feeds, and in many cases are intended to treat or prevent disease without first undergoing proper drug approval.3

There is no generic Adequan® i.m.

Adequan® i.m. is an FDA pioneer drug that has no generic, and there is no product that is "just like Adequan only cheaper." A 'generic' drug is bioequivalent to a pioneer drug in dosage form, efficacy, safety and strength, route of administration, quality, and intended use. Adequan i.m. is the ONLY FDA-Approved polysulfated glycosaminoglycan (PSGAG) for the intramuscular treatment of non-infectious degenerative joint disease (DJD) of the carpal and hock joints.

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How to identify an FDA-Approved drug.

All FDA-Approved veterinary pharmaceutical pioneer products carry a six-digit New Animal Drug Application (NADA) number. Most drug manufacturers list the number and the statement, "Approved by FDA," on the drug's label. If the product you are using does not have this number, it has not been approved through the FDA. Approved generic animal drugs have an Abbreviated New Animal Drug Application (ANADA) number assigned by the FDA, which you can typically find on the drug's label.4 Compounds and unapproved drugs lack any FDA assigned number.4

Helpful references on equine joint therapy for veterinarians*

We have developed these references to give veterinarians a clear understanding of therapy options to guide your recommendations for patients. Some of the products currently being used for joint therapy within the industry are being prescribed, used and/or marketed improperly.

Equine Joint Therapy Product Guide*

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Technical Bulletin: The Difference is in the Details*

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*The content of this educational brochure was developed as a reference guide and contains information on products that are currently being used within the equine industry.
INDICATIONS
Adequan® i.m. (polysulfated glycosaminoglycan) is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.
IMPORTANT SAFETY INFORMATION There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan. Studies have not been conducted to establish safety in breeding horses. WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. For full prescribing information, click here.
1. Equine Veterinary Compounding Guidelines. American Association of Equine Practitioners, http://www.aaep.org/custdocs/drug_compounding_guidelines.pdf. Accessed October 16th, 2019.
2. The Biological and Therapeutic Agents Committee. Medical Devices: A White Paper on Medical Devices in Equine Medicine. American Association of Equine Practitioners. Approved by the AAEP Board of Directors July 2010. Accessed October 16th, 2019.
3. Compliance Policy Guide, CPG Sec. 690.100 Nutritional Supplements for Companion Animals, March 1995, FDA, Center for Veterinary Medicine, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cpg-sec-690100-nutritional-supplements-companion-animals . Accessed October 16, 2019.
4. New Animal Drug Applications, June 20, 2019, FDA, Center for Veterinary Medicine, https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications. Accessed November 12, 2019.

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