Zeftera (ceftobiprole medocaril) for Injection - Discontinuation of Sale - Notice to Hospitals

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Contact: Marketed Health Products Directorate

The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

This is duplicated text of a letter from Janssen-Ortho Inc.
Contact the company for a copy of any references, attachments or enclosures.

Notice to Hospitals
Health Canada Endorsed Important Safety Information on ZEFTERA
(ceftobiprole medocaril) for Injection

April 9, 2010

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments of Surgery, Medicine, Intensive Care, Anesthesiology, Emergency, Nursing, Pharmacy, Laboratory Services, and other involved professional staff and post this NOTICE in your institution.

Subject: Discontinuation of Sale of ZEFTERA^* (ceftobiprole medocaril) for Injection

Janssen-Ortho is discontinuing sale of ZEFTERA (ceftobiprole medocaril) for Injection effective April 16^th, 2010.

ZEFTERA is currently approved for the treatment of complicated skin and skin structure infections including non-limb-threatening diabetic foot infections without concomitant osteomyelitis caused by Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Staphylococcus aureus (including methicillin-resistant isolates) and Streptococcus pyogenes.

This action is being taken by Janssen-Ortho following discussions with Health Canada in response to recent regulatory recommendations in the United States and European Union to not approve ZEFTERA for this indication due to concerns regarding the conduct of clinical trials.

Consistent with the decision to discontinue sale of ZEFTERA, Janssen-Ortho is asking Canadian distributors to return any product remaining in their inventories after April 16^th, 2010. Further directions on how to handle product returns will be communicated to distributors in the next few business days.

Advice to Health Care Professionals:

Prescribers are advised:

• To allow all patients on the product to complete their course of therapy
• Not to initiate treatment of new patients

The identification, characterization, and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse drug reaction reporting programs. Any occurrences of serious and/or unexpected adverse reactions in patients receiving ZEFTERA should be reported to Janssen-Ortho Inc. or the Marketed Health Products Directorate at the following addresses:

Health Canada asks that you share these recommendations with your staff or membership and encourage their implementation.

Should you have any questions or require additional information, please contact Janssen-Ortho Inc. Medical Information Department at 1-800-567-3331 from 9:00 am to 5:00 pm Monday to Friday Eastern Standard Time (EST) or by Facsimile at 416-449-2658.

Sincerely,

original signed by

Cathy Lau, PhD.
Vice President
Regulatory and Quality

*All trademark rights used under license.