Navigation Links
Endo Announces Potential Short-Term Supply Constraints of Certain Analgesic Medications as a Result of Temporary Shut Down of Novartis Facility

CHADDS FORD, Pa., Jan. 9, 2012 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that, as a result of a temporary shut-down of Novartis Consumer Health Inc.'s Lincoln, Neb., manufacturing facility, there will be a short-term supply constraint of OPANA® ER.  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.

About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company with a diversified business model, operating in three key business segments – branded pharmaceuticals, generics and devices and services.  We deliver an innovative suite of complementary products and services to meet the needs of patients in areas such as pain management, pelvic health, urology, endocrinology and oncology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries American Medical Systems and Qualitest Pharmaceuticals, as well as its affiliate HealthTronics, Inc., please visit

Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements.  Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


SOURCE Endo Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... 2016  MedSource announced today that it has ... solution of choice.  This latest decision demonstrates MedSource,s ... their clients by offering a state-of-the-art electronic data ... nowEDC as the EDC platform of choice in ... "nowEDC has long been a preferred EDC platform ...
(Date:6/23/2016)... HILLS, Calif. , June 23, 2016 Any ... the many challenges of the current process. Many of them ... because of the technical difficulties and high laboratory costs involved. ... have to offer it at such a high cost that ... afford it. Dr. Parsa Zadeh , founder ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a ... can give their videos a whole new perspective by using the title layers ... Film Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... Miami, FL (PRWEB) , ... June 25, 2016 , ... The temporary closing of Bruton ... Plant City Observer , brings up a new, often overlooked aspect of head lice: ... The closing for fumigation is not a common occurrence, but a necessary one in the ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
Breaking Medicine News(10 mins):