Horse owners who use Adequan for their equines’ joint health will continue feeling the pain of not having product.
Luitpold Pharmaceuticals says previously limited supplies are now depleted. The company estimates Adequan will be available after January 2014. Ultimately, the date hinges upon completion of a successful facility inspection by the FDA.
The product supply issues were precipitated by the company receiving a warning letter from the FDA in August 2011 referencing “significant violations.” The FDA cited Luitpold for violations of good manufacturing practice, including ill-defined or scientifically unjustified operating procedures which contributed to “persistent” particulate contamination.
The facility is undergoing renovations and upgrades to meet the FDA’s standards, so the manufacturing of product was halted.
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. The company says owners should work with their veterinarians to find the safest and most effective alternative treatment until Adequan is back in production.
If you have questions, you can call the company’s customer service department at 1-800-458-0163.