Natrecor (nesiritide) - Notice of Compliance with Conditions - Qualifying Notice

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

Contact: BGTD RAD Enquiries

Biologics and Genetic Therapies Directorate
200 promenade Tunney's Pasture Driveway
Address Locator #0701A
Ottawa, Ontario
KlA 0K9

9427-J0921-98

September 21, 2007(signed)

[employee's name removed]
Director, Regulatory Affairs
Janssen-Ortho Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
Fax: 416-449-7092

Dear [employee's 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 (NDS) for Natrecor (nesiritide), Control # 111760, qualifies to be considered for approval, 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 of the above mentioned NDS:

1. a letter signed by the Chief Executive Officer, or designated signing authority, indicating if Janssen-Ortho Inc., the sponsor, agrees to have the submission considered under the NOC/c Policy.
2. a Letter of Undertaking signed by the Chief Executive Officer, or designated signing authority, of Janssen-Ortho Inc., revised to include:
   1. a commitment to provide Health Canada with the completed study report for the confirmatory study, as soon as it is available;
   2. the timeline for the confirmatory study;
   3. a commitment to provide Adverse Drug Reaction reports in relation to the confirmatory trial to Health Canada in accordance with the Food and Drug Regulations and the Guidance for Industry, Notice of Compliance with Conditions(NOC/c);
   4. a commitment to conducting and completing the confirmatory study and submitting to Health Canada the associated Supplemental New Drug Submission - Confirmatory (S/NDS-C) within 5 years following issuance of a NOC/c; and
   5. please specify that Adverse Drug Reactions for the marketed product will be reported to Health Canada in accordance with the current Guidelines for Reporting Adverse Reactions to Marketed Drugs and the Guidance for Industry, Notice of Compliance with Conditions (NOC/c).
   In addition, note that the format and content of Periodic Safety Update Reports (PSUR-C) submitted on a semi-annual basis should be in accordance with ICH Guidelines, as per Section 6.2.2 of the Guidance for Industry, Notice of Compliance with Conditions (NOC/c).
3. the Dear Health Care Professional Letter which is to be issued by you, for our assessment [refer to Appendix 3 of the Guidance for Industry, Notice of Compliance with Conditions (NOC/c)].
4. the Product Specific Fact Sheet which is to be issued by you, for our assessment [refer to Appendix 4 of Guidance for Industry, Notice of Compliance with Conditions (NOC/c)].

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 to the date of this letter.

In order to facilitate proper processing, please include a revised Submission Certificate with your response, quote the product name and control number, and address all correspondence to the Chief, Submission and Information Policy Division, Bureau of Operational Services, Therapeutic Products Directorate, 1^st Floor, Finance Building, 101 Tunney's Pasture Driveway, Address Locator 0201A1, Tunney's Pasture, Ottawa, Ontario, K1A 0K9.

Yours sincerely,

Original signed by
Dr. Agnes V. Klein for:
Dr. Elwyn Griffiths
A/Director General