Qualifying Notice - Co-Memantine

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Contact: Bureau of Pharmaceutical Sciences

Notice of Compliance With Conditions - Request For Letter of Undertaking

Therapeutic Product Directorate
Holland Cross, Tower "B"
6th Floor, 1600 Scott Street
Address Locator #3106B
OTTAWA, Ontario
K1A 0K9

9427-C1995-140

[employee name removed]
Vice-President, Regulatory Affairs
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, ON
L5N 2B8

Dear [employee name removed]:

This letter is to advise you that information submitted in support of the Abbreviated New Drug Submission for CO MEMANTINE (Memantine Hydrochloride), Control Number 122439, for its use in the symptomatic treatment of patients with moderate to severe dementia of the Alzheimer's type, qualifies to be considered for authorization under the Notice of Compliance with Conditions (NOC/c) Policy. In keeping with the provision outlined in Part C, Section C.08.002.1 (3) (d) of the Food and Drug Regulations, the following additional information is required to complete the assessment:

1. A letter signed by the Chief Executive Officer, or designated signing authority of Cobalt Pharmaceuticals Inc., indicating that you agree to have this submission considered under the NOC/c Policy. Please be reminded that in agreeing to accept a Notice of Compliance (NOC) under the NOC/c Policy, Cobalt Pharmaceuticals Inc., consents to the posting of the NOC/c- Request for Letter of Undertaking on Health Canada's website once market authorization has been received.
2. A Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority of Cobalt Pharmaceuticals Inc. having a form and content satisfactory to Health Canada to provide the following.
   
   Post Market Safety Monitoring
   1. Periodic Safety Update Reports (PSUR) on a 6 month frequency basis. The PSUR reporting frequency will be re-assessed 2 years post launch. PSURs should be prepared in accordance with International Conference on Harmonisation (ICH) Guidelines and should be submitted in paper and electronic (bookmarked and searchable) formats.
   2. Reports of all serious Adverse Reactions (ARs) that occur in Canada and all serious unexpected ARs that occur outside of Canada, shall be forwarded within 15 days to Health Canada. One copy should be provided to the Marketed Health Products Directorate and another copy to the Bureau of Cardiology, Allergy and Neurological Sciences in the Therapeutic Products Directorate in accordance with current regulations and guidelines.
   3. Notification and reporting on specific issues of concern as outlined in Section 6.2.4 of the Guidance for Industry, Notice of Compliance with Conditions.
3. A draft "Dear Health Care Professional Letter" detailing the issuance of a NOC under the NOC/c Policy and a draft "Product Specific Fact Sheet" outlining in lay language the potential risks, benefits and side effects of CO MEMANTINE.
4. A draft of the Product Monograph which is consistent with the requirements outlined in Section 5.2.1 of the Guidance for Industry, Notice of Compliance with conditions. Please note that a boxed text must appear on the cover page, at the beginning of each major section of the Product Monograph (Parts I, II and III, if applicable), disclosing the nature of the authorization granted for CO MEMANTINE and the need to complete  confirmatory studies by the innovator for the conditions to be lifted. 

I wish to advise you that this letter is being issued in accordance with Health
Canada's Notices to Stakeholder dated April 2nd, 2008 and March 17, 2009. Sponsors are instructed to submit a complete response (refer to Guidance for Industry; Notice of Compliance with Conditions, similar to the innovator) to the outstanding information within 30 calendar days of the date of this letter.

In order to facilitate and to ensure proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to the Submission and Information Policy Division, Therapeutic Products Directorate, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Tunney's Pasture, Ottawa, Ontario, K1A 0K9.

Yours sincerely,

Supriya Sharma, MD MPH FRCPC
Director General

SS/res