Endo Pharmaceuticals (NASDAQ:ENDP) faces a drug shortage risk for some of its opiates, such as Percocet, as Novartis Consumer Group sorts out a mix-up that could cause extended release opiates for Endo Pharmaceuticals to be bottled together with over-the-counter pain reliever Excedrin and stimulant NoDoz.
The factory shutdown, though temporary, could cause a shortage for Endo’s painkiller drugs like Endocet and Zydone, as well as Percocet.
The U.S. Food and Drug administration called attention to the problem in a public health advisory. It alerted healthcare professionals and patients of the problem tied to Novartis Consumer Health’s Lincoln, Nebraska manufacturing site. “Due to problems that occurred when these products were packaged and labeled at the site, tablets from one product type may have carried over into packaging of another product,” the statement read.
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Julie McHugh, chief operating officer of Endo Pharmaceuticals, said the company was working with the FDA to minimize disruption for patients using these drug treatments. She said: “Given existing inventories, the expected restart of Novartis production and our ability to shift production to other facilities, we believe the supply constraints of our products should be limited. With Novartis as the sole manufacturer of the current formulation of Opana ER, we plan to temporarily moderate demand of the product by asking physicians to refrain from starting new patients on Opana ER in order to minimize disruption for patients currently on the product.”
As a result of the Novartis facility shutdown, Endo will be expediting the production of products at alternative manufacturing facilities in Huntsville, Alabama.
Novartis initiated a voluntary recall, according to a statement on its website, and said it would take an estimated $120 million charge tied to the drug recall and factory improvements in the fourth quarter.
Endo, in Chadds Ford, Pennsylvania, saw a 439 percent surge in generic drug sales in the third quarter of 2011 over the previous year to $148 million, primarily driven by its acquisition of Qualitest Pharmaceuticals in Huntsville.
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Endo is preparing to relocate to larger facilities in Malvern, Pennsylvania by December 2012 as part of a long-term growth strategy.
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