Luitpold Pharmaceuticals, Inc. Provides Adequan® (polysulfated glycosaminoglycan) Supply Update
Shirley, NY (June 27, 2013) – Luitpold Animal Health, a division of Luitpold Pharmaceuticals, Inc., manufacturers of Adequan® IM, Adequan® IA, and Adequan® Canine provide the following supply interruption update:
Luitpold’s NY facility has undergone significant renovations and upgrades to meet enhanced quality standards and address observations made by the U.S. Food and Drug Administration (FDA). These renovations required cessation of manufacturing and affected Luitpold’s ability to release product. This has resulted in shortages in the marketplace. Luitpold has worked in recent months to optimally allocate inventory and manage the limited remaining supply, which has now been depleted.
Luitpold remains committed to resuming its manufacture and release of Adequan® products. We understand how critically important the Adequan® brands are to the health and well-being of the animals receiving treatment. The company’s latest expectations for reestablishing Adequan® supply to the market is estimated to be first quarter 2014 however, this hinges upon completion of a successful inspection by the FDA.
The company has established a dedicated webpage on www.adequan.com where concerned parties can register to receive future communications and updates on this matter. You may also contact our Customer Service Department at 1-800-458-0163.
During this supply interruption, we strongly recommend Veterinarians work together with equine and canine owners and caregivers to evaluate and decide upon the safest and most effective alternative treatments.
Adequan® IM and IA are the only polysulfated glycosaminoglycan (PSGAG) approved by the FDA for the treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness in horses. Adequan® Canine is the only polysulfated glycosaminoglycan (PSGAG) approved by the FDA for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints.
Contact
Allyn Mann, Director
Luitpold Animal Health
Cell Phone: 816-590-5032
Email: amann@adequan.com
There are no known contraindications to the use of intramuscular Adequan® IM brand Polysulfated Glycosaminoglycan in horses. 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. Each 5 mL contains 500 mg Polysulfated Glycosaminoglycan. Brief Summary Indications: For the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.
Inflammatory joint reactions and septic arthritis have been reported following administration of Adequan® IA. Joint sepsis, a rare but potentially life threatening complication, can occur after intra-articular injection. Use only in the carpal joint of horses. Do not use in horses intended for human consumption.
Adequan® Canine (polysulfated glycosaminoglycan or PSGAG) should not be used in dogs who are hypersensitive to PSGAG or who have a known or suspected bleeding disorder. It should be used with caution in dogs with renal or hepatic impairment. Possible side effects (pain at injection site, diarrhea and abnormal bleeding) were mild, transient and self-limiting. Safety studies of PSGAG in breeding, pregnant or lactating dogs have not been conducted.
See Full Prescribing Information for each ADEQUAN® product at www.adequan.com
Adequan® is a registered trademark of Luitpold Pharmaceuticals, Inc. ©LUITPOLD PHARMACEUTICALS, INC., Animal Health Division, Shirley, NY 11967.
