NOTIFICATION ON LIMITED AVAILABILITY OF SINEMET® AND SNEMETCR® FROM LATE 2009
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This following information has been provided by Merck & Co., Inc to help answer any queries from EPDA members.
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It is a world-wide shortage, hoarding has already begun, and there has been no explanation:
"I am writing to inform you of an expected supply interruption in SINEMET® (carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa controlled release). At Merck Sharp & Dohme Limited (MSD), we are working hard to help minimize the impact that this shortage will have on some Parkinson's patients and their physicians.
Starting in late 2009 and continuing into 2011 MSD will experience a significant global supply shortage of SINEMET and SINEMET CR. This temporary shortage is related to a change in the source of supply for the drug and the necessary timelines needed to obtain regulatory approvals for this supply change. It is important to note that this situation is not due to product quality or safety issues, nor is it due to delays on the part of individual regulatory agencies that approve this supply change.
To address the expected shortfall, Merck & Co., Inc. (Merck), our parent company, and MSD are taking action to manage available supply of these products through a process that primarily takes into account patient needs, as well as availability of alternative treatments (which exist in most markets), and contractual obligations. In accordance with our analysis, some markets will get their full needs met, many will experience a significant shortfall in their supply, and many will not get any supply of these products. "