Qualifying Notice for DOCETAXEL for Injection

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Contact: Bureau of Metabolism, Oncology and Reproductive Sciences

Notice of Compliance with Conditions - Qualifying Notice

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

9427-H0928/1-66

January 25, 2011 (signed)

[employee name removed]
Director, Scientific Affairs
Hospira Healthcare Corporation
1111 Dr. Frederik Philips, Suite 600
Saint-Laurent, Quebec
H4M 2X6

Dear [employee name removed]:

This Notice of Compliance with Conditions (NOC/c) Qualifying Notice, issued in accordance with the Health Canada NOC/c Policy, is to advise you that information submitted in support of the New Drug Submission for DOCETAXEL FOR INJECTION, Control Number 116151, for the indication of adjuvant treatment of patients with operable node-positive breast cancer, qualifies to be considered for authorization under the NOC/c Policy. In keeping with the provisions outlined in the NOC/c Policy, the following additional information is required to complete the assessment:

1. A letter, signed by the Chief Executive Officer or designated signing authority of Hospira Healthcare Corporation, indicating that you agree to have this submission considered under the NOC/c Policy. Please be reminded that in agreeing to accept an NOC under the NOC/c Policy, Hospira Healthcare Corporation consents to the posting of the NOC/c-QN on Health Canada's website.
2. A draft Letter of Undertaking signed by the Chief Executive Officer or designated signing authority of Hospira Healthcare Corporation, having a form and content satisfactory to Health Canada, including commitments to supply the following:
   
   Post Market Safety Monitoring Studies
   
   1. Report of all serious Adverse Drug Reactions (ADRs) that occurred in Canada and all serious unexpected ADRs that occurred outside of Canada should be forwarded within 15 days to the Marketed Health Products Directorate.
   2. Periodic Safety Update Reports (PSUR-Cs), to be submitted yearly to the Therapeutic Products Directorate. PSURs should be prepared in accordance with International Conference on Harmonisation ICH Guidelines.
3. A draft of the "Dear Health Care Professional Letter". The letter should detail:
   1. the preparation information describing that DOCETAXEL for Injection concentration and preparation procedures are different than other marketed DOCETAXEL products.
   2. the issuance of a Notice of Compliance under the NOC/c Policy for DOCETAXEL for Injection for the indication of adjuvant treatment of patients with operable nodepositive breast cancer.
4. A draft of the "Fact Sheet" outlining in lay language the potential risks, benefits and side effects of DOCETAXEL for Injection for the indication of adjuvant treatment of patients with operable node-positive breast cancer.
5. A draft of the Product Monograph that is consistent with the requirements outlined in section 5.2.1 of the Notice of Compliance with Conditions Guidance. 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) and the first page, disclosing the nature of the authorization granted for DOCETAXEL for Injection and stating that results of studies verifying its clinical benefit are pending.

I wish to advise you that this Qualifying Notice is being issued in accordance with Health Canada's guidance and policy on the Management of Drug Submissions and Notice of Compliance with Conditions, respectively. Sponsors are instructed to submit a complete response (refer to "Guidance for Industry; Notice of Compliance with Conditions") 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 Director, Submission and Information Policy Division, Director General's Office, Therapeutic Products Directorate, Finance Building, Tunney's Pasture, Address Locator 0201A1, Ottawa, Ontario, K1A 0K9.

Yours sincerely,

Original signed by B.J. Sabourin for:

Supriya Sharma, MD MPH FRCPC
Director General