Yesterday, Luitpold, the manufacturer of Adequan (R) announced that they would not have product available until the first quarter of 2014. Originally, the company predicted the product would come on line again this July. For many horse and dog owners, that’s really bad news because the drug is almost impossible to find. Even worse, there’s now a shortage of Pentosan as Adequan users have bought up inventory of Wedgewood’s product.
According to a press release from Luitpold:
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 remains committed to resuming its manufacture 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 truth may be a bit more complicated. In 2011 the FDA cited Luitpold Pharmaceuticals for “significant” manufacturing violations, for injectable drugs (not Adequan). According to an article in Fierce Pharma,
The FDA letter to Luitpold Pharmaceuticals cites “significant” violations–and in a second round of inspections to boot. The facility had been inspected in February and March and then shut down in April for fixes, but the FDA wasn’t satisfied with the results. In fact, Luitpold-made products–distributed by American Regent–have been recalled several times this year, some of them because drug vials contained visible particles.
The key problem is particulates found in injectable drugs. The agency said Luitpold’s failures to fully investigate particulates and look into product failures were “repeat violations” that cropped up in annual inspections since 2008, Dow Jones reports. The Daiichi unit said it believes it has dealt with “most if not all” of the manufacturing shortfalls pointed out by the FDA.