Product Approval Information - Licensing Action
October 13, 2006
Our STN: BL 103665/5119
Novo Nordisk, Inc.
Attention: Mary Ann McElligott, Ph.D.
100 College Road West
Princeton, New Jersey 08540
Dear Dr. McElligott:
We have approved your request to supplement your biologics license application for Coagulation Factor VIIa (Recombinant)[ NovoSeven], for the treatment of bleeding episodes and for prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.
We acknowledge your written commitments as described in your letter of October 5, 2006 as outlined below:
Postmarketing Studies subject to reporting requirements of 21 CFR 601.70.
To collect data on all acquired hemophilia patients, regardless of treatment, in the HTRS registry established at 72 sites within 6 months of approval of the indication for five years. Data will be collected to further evaluate efficacy and safety of NovoSeven. The efficacy evaluation will consist of hemostatic rating of excellent/good, fair/partially effective and poor /ineffective by investigators at 24 and 72 hours after drug administration. In addition to the rating a comment by the investigator will be captured to support the rating chosen. Data will also be collected on dose, concomitant hemostatic agents, impact of Novo Seven as either first line or second line agent, impact upon timing of treatment initiation to treatment outcome, and impact of underlying disease, if any.
Please submit clinical protocols to your IND, with a cross-reference letter to this biologics license application (BLA), STN: BL 103665/5119. Submit nonclinical and chemistry, manufacturing, and controls protocols and all study final reports to your BLA STN BL 103665/0. If the information in the final study report supports a change in the labeling, the final study report should be submitted as a supplement. We may also request a supplement if we think labeling changes are needed. Please use the following designators to label prominently all submissions, including supplements, relating to these postmarketing study commitments as appropriate:
- Postmarketing Study Protocol
- Postmarketing Study Final Report
- Postmarketing Study Correspondence
- Annual Report on Postmarketing Studies
For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for this product. The status report for each study should include:
- information to identify and describe the postmarketing commitment,
- the original schedule for the commitment,
- the status of the commitment (i.e. pending, ongoing, delayed, terminated, or submitted), and
- an explanation of the status including, for clinical studies, the patient accrual rate (i.e. number enrolled to date and the total planned enrollment).
As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies on our Internet site (http://www.fda.gov/cder/pmc/default.htm). For further information, please refer to the April 2001 Draft Guidance for Industry: Reports on the Status of Postmarketing Studies - Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (see http://www.fda.gov/cber/gdlns/post040401.htm).
Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.
We will include information contained in the above-referenced supplement(s) in your biologics license application file(s).
Sincerely yours,
--- signature ---
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research