The company also announced certain other Endo analgesic products manufactured at this facility may experience short-term supply disruptions.
Endo is working closely with the U.S. Food and Drug Administration (FDA) and Novartis to minimize patient disruptions and promptly resume production of Endo's products at the Lincoln facility.
The suspension of production at the Lincoln, Neb. facility was done to facilitate Novartis's implementation of certain manufacturing process improvements. These improvements are intended to address the possibility of rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups. The temporary supply disruption is not related to the efficacy or safety of Endo's products.
"We are working collaboratively with the FDA to minimize the disruption to patients currently on therapy. 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," said Julie McHugh, chief operating officer of Endo Pharmaceuticals. "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.
We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products for current patients."
As a result of the Novartis facility shutdown, Endo will be expediting the production of products at alternative manufacturing facilities. Endo has initiated the manufacturing of PERCOCET® and ENDOCET® at its Huntsville, Ala., facility and expects minimal disruption to patients on these products.
Separately, Endo also has plans to put additional procedures in place to assist Novartis in restarting production at the Lincoln, Neb., manufacturing facility. In addition to the short-term supply constraint of Opana ER, the Endo medicines that may experience a short-term supply disruption include the following products manufactured at the Lincoln facility:
-- OPANA® (oxymorphone hydrochloride) Tablets CII
-- Oxymorphone Hydrochloride Tablets CII
-- PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
-- PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
-- ENDOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
-- ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
-- Morphine Sulfate Extended-Release Tablets CII
-- ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
Endo filed a Form 8-K with the U.S. Securities and Exchange Commission today to provide additional detail regarding the current situation at the Novartis manufacturing facility.
Endo is working closely with the U.S. Food and Drug Administration (FDA) and Novartis to minimize patient disruptions and promptly resume production of Endo's products at the Lincoln facility.
The suspension of production at the Lincoln, Neb. facility was done to facilitate Novartis's implementation of certain manufacturing process improvements. These improvements are intended to address the possibility of rare instances of errors in the packaging of the tablets, potentially resulting in product mix-ups. The temporary supply disruption is not related to the efficacy or safety of Endo's products.
"We are working collaboratively with the FDA to minimize the disruption to patients currently on therapy. 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," said Julie McHugh, chief operating officer of Endo Pharmaceuticals. "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.
We currently expect this to be a short-term issue and we remain focused on working with the healthcare community to optimize the continued supply of our products for current patients."
As a result of the Novartis facility shutdown, Endo will be expediting the production of products at alternative manufacturing facilities. Endo has initiated the manufacturing of PERCOCET® and ENDOCET® at its Huntsville, Ala., facility and expects minimal disruption to patients on these products.
Separately, Endo also has plans to put additional procedures in place to assist Novartis in restarting production at the Lincoln, Neb., manufacturing facility. In addition to the short-term supply constraint of Opana ER, the Endo medicines that may experience a short-term supply disruption include the following products manufactured at the Lincoln facility:
-- OPANA® (oxymorphone hydrochloride) Tablets CII
-- Oxymorphone Hydrochloride Tablets CII
-- PERCOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
-- PERCODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
-- ENDOCET® (oxycodone hydrochloride and acetaminophen USP) Tablets CII
-- ENDODAN® (oxycodone hydrochloride and aspirin, USP) Tablets CII
-- Morphine Sulfate Extended-Release Tablets CII
-- ZYDONE® (hydrocodone bitartrate/acetaminophen tablets, USP) CIII
Endo filed a Form 8-K with the U.S. Securities and Exchange Commission today to provide additional detail regarding the current situation at the Novartis manufacturing facility.
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