Why There is No Generic Adequan®
Tuesday, February 17, 2015
“THERE IS NO GENERIC ADEQUAN®i.m.” is a well-known phrase, due to the bold ads in every equine magazine and on HorsesDaily.com. Announcer Nicho Meredith for the Adequan Global Dressage Festival mentions the phrase when thanking Adequan for their continued support. Adequan® is polysulfated glycosaminoglycan, the only drug approved by the FDA for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness in the carpal and hock joints in equines. Plain and simple. However, one does question why that is the case. What is a generic drug? According to the FDA website, a generic drug has to be equivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Learn what goes into producing ADEQUAN®i.m.
Generic drugs are as effective as the brand-name because the FDA requires them to have the same quality, strength, purity, and stability as brand-name drugs, and to demonstrate bioequivalence to the innovator drug.
A few notes about generic drugs:
- Companies manufacturing generic drugs through their approved abbreviated new animal drug application (ANADA) are not required to go through the exact same clinical research on the ingredients that were already approved for safety and effectiveness like the original manufacturer.
- Generic drugs do, however, have to contain the same active ingredients as the original, but inactive ingredients may vary, although with injectable drugs like ADEQUAN®i.m. they need to be the same.
- Everything else has to be the exact replica—same strength, dosage form, administration practices—as well as meet the same batch requirements for quality, strength, and identity.
- All generic drugs must be manufactured under the same strict standards outlined by the FDA that the original manufacturer follows for good manufacturing practice regulations.
- Generic drugs can save consumers millions of dollars every year,
But there is NO GENERIC Adequan®.
“The manufacturing process for Adequan® takes 24 months—it takes us two years to go from raw material all the way to release of the finished product,” explains Victoria Maxwell, DVM, MBA, Senior Manager of Professional Veterinary Services for Adequan®. “Somebody would have to start that process and for two years make no profit in order to turn out their first vial of Adequan® to come even close to what we do.”
This is the third in a series introducing and educating readers on the Adequan® i.m.(polysulfated glycosaminoglycan) product and its proper use. Stay tuned to HorsesDaily.com as the series continues.
In the next article, you will learn more about the FDA’s role in regulating Adequan® (polysulfated glycosaminoglycan) and why it is important for the horse owner, veterinarian, and the horse.
Adequan® i.m.: For the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. There are no known contraindications to the use of intramuscular Adequan® i.m. brand Polysulfated Glycosaminoglycan in horses. Studies have not been conducted to establish safety in breeding horses. Each 5 mL contains 500 mg Polysulfated Glycosaminoglycan. 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.
SEE PRODUCT PACKAGE INSERTS FOR FULL PRESCRIBING INFORMATION by going to www.adequan.com, or by calling (800) 458-0163. Adequan® is a registered trademark of Luitpold Pharmaceuticals, Inc. ©LUITPOLD PHARMACEUTICALS, INC., Animal Health Division, Shirley, NY 11967. © 2015
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