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Friday, July 26, 2013

Adequan Availability Update

Dressage-news.com

The manufacturer of Adequan estimates the United States Federal Drug Administration will inspect the plant in New York that makes the product in late summer but production may not be resumed for several months.

The New York production plant, the only manfacturing facility of Adequan in the world, has been closed for renovations ordered by the FDA and supplies are most likely exhausted, said Allyn Mann, director of Luitpold Animal Health that manufactures the polysulfated glycosaminoglycan for horses and dogs.

Supplies of Adequan were interrupted by the “significant renovations and upgrades to meet enhanced quality standards” ordered by the FDA, the company said.

“These renovations required cessation of manufacturing and affected Luitpold’s ability to release product. This has resulted in shortages in the marketplace.

“Manufacturing cannot resume until the renovations are completed and approved by the FDA.

“Our regulatory group estimates it (renovations) will happen late summer,” Allyn Mann said. “There will be some dialogue with FDA after the inspection which could take several weeks or as long as several months depending on how it goes.

“Once we get clearance, product will ship immediately.”

Adequan IM and IA are the only polysulfated glycosaminoglycan 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 approved by the FDA for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints.

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