Complaints about Trileptal (FDA)

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Reference: FDA1961489
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

Jeffrey Brown Jeffrey Brown
Re: Confirmation # FDA1961489
Requester Ctrl #:
In Reply refer to: 2020-133
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
A copy of all complaints submitted to MedWatch, a Consumer Complaint Coordinator or the Office of Prescription Drug Promotion concerning Trileptal (Oxcarbazepine) made between January 1, 2000 and the date this request is processed.
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.
Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and whether sensitive records, voluminous records, extensive search, and/or consultation with other HHS components or other executive branch agencies are involved. Please note that requests for medical device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.
If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at 301-796-8982 or write to us at:
Division of Freedom of Information,
U.S. Food and Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
Fax: 301-827-9267
You also have the right to seek dispute resolution services from:
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and/or:
Office of the Executive Secretariat
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Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov
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Hello,

We have received your FOIA requests. Please give me a call to discuss fees and wait times regarding your requests. My direct contact information is listed below. I contacted the number listed on the request and was told you are not located at that site. Thank you.

Darshini Satchi
Branch Chief FOI Team
Division of Information Disclosure Policy
CDER
301-796-3496

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Hello,

I'm following up to my earlier e-mail. Thanks.