Thread: sound familiar?
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Old 01-11-2011, 05:17 PM
paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
paula_w paula_w is offline
In Remembrance
 
Join Date: Aug 2006
Location: Florida
Posts: 3,904
15 yr Member
Default sound familiar?

Amy Rick gave her permission to share. Bob Dawson where are you? I gave her the Spanish story....thanks for all your help and we need you to make noise again.
thank you!


Michael Rosenblatt
Executive Vice President
Chief Medical Officer
Merck WS3A-20

T 908-423-6446
F 908-423-1447
merck.com & Co. Inc.


December 20, 2010

Amy Comstock Rick, J.D.
Chief Executive Officer
Parkinson's Action Network
1025 Vermont Avenue, Suite 1120
Washington D.C. 20005

Dear Ms. Rick:

Merck (known as MSD outside the U.S. and Canada) is committed to providing you with
up-to-date information about our products. This letter is to inform you of a potential
temporary supply issue that may occur in the U.S. in early 2011 for SINEMET®
(carbidopa-levodopa) and SINEMET CR® (carbidopa-levodopa controlled release
tablets).

Currently, Merck manufactures SINEMET for supply in the U.S. and globally, and Bristol
Myers Squibb distributes the product in the U.S. At the end of this year, Merck will
regain the marketing and distribution rights to SINEMET in the U.S. Concurrently, Merck
has filed an application with the FDA to change the manufacturing supply source of
SINEMET from Merck to a new source, a process that requires regulatory approval. As a
result of these two events, a potential temporary supply shortage may occur in early
2011 across some of the dosages. This potential shortage is not related to any product
safety or quality issues.

Merck continues to work with the FDA on the manufacturing supply source change. In
the meantime, while we are not experiencing a supply shortage currently, we want to
ensure that you are fully informed so that if necessary, you can inform patients in a
timely manner and provide them with relevant information about potential short-term
alternative therapies, including availability of alternative generic equivalents, as
appropriate.

Merck understands how difficult it is for any patient who may not be able to receive their
usual medication. We also recognize that some patients may express concerns if their
physician switches therapy from a branded to a generic medicine. We encourage all
patients and caregivers who have questions about their treatment options to speak to
their health care provider.

Should a supply shortage occur, any patient, caregiver or health care professional in the
U.S. who has a question about the availability of SINEMET should contact the Merck
National Service Center at 1-800-NSC-MERCK.

Please be assured that Merck will continue to monitor this matter very closely and will
inform you as soon as we confirm any supply shortages. Merck is committed to acting in
the best interests of patients.

Sincerely,
Michael Rosenblatt, M.D.
Chief Medical Officer
Merck & Co., Inc.
One Merck Drive
Whitehouse Station, NJ 08889WS3A-20
__________________
paula

"Time is not neutral for those who have pd or for those who will get it."
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