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CATENA® (idebenone) - Voluntary withdrawal of CATENA® from the Canadian market - For Health Professionals
- Starting date:
- February 27, 2013
- Posting date:
- February 27, 2013
- Type of communication:
- Dear Healthcare Professional Letter
- Source of recall:
- Health Canada
- Product withdrawal
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Santhera Pharmaceuticals Canada Inc. Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Information on CATENA® (idebenone)
February 27, 2013
Dear Health Care Professional,
Subject: Withdrawal of CATENA® (idebenone) for the treatment of Friedreich’s Ataxia from the Canadian market
Santhera Pharmaceuticals, in consultation with Health Canada, would like to inform you of its decision to voluntarily withdraw CATENA® from the Canadian market, as of April 30, 2013.
- Santhera Pharmaceuticals will voluntarily withdraw CATENA from the Canadian market as of April 30, 2013.
- The withdrawal of CATENA® is based on the negative outcome of additional confirmatory efficacy studies required by Health Canada and is not the result of a specific safety concern.
- Prescribers are advised to discuss alternative treatment options with their patients before April 30, 2013.
CATENA® was authorized with conditions in Canada in July 2008 on the basis that it demonstrated promising evidence of clinical safety and efficacy in the symptomatic management of patients with Friedreich’s Ataxia.
One of the conditions of authorization was to provide confirmatory evidence of efficacy in further clinical studies. However, the additional studies completed to date failed to meet their primary efficacy endpoint.
Following discussions with Health Canada, Santhera has agreed to voluntarily withdraw CATENA® from the Canadian market for the treatment of Friedreich’s Ataxia.
No specific safety issues were identified that have prompted this action, and the withdrawal does not preclude the submission of a new application for market authorization in the future.
Since no prescriptions will be filled after close of business on April 30, 2013, prescribers are advised to discuss alternative treatment options with their patients as soon as possible. Santhera will not make CATENA® available through Health Canada’s Special Access Programme. Also, Santhera will not recall CATENA® currently prescribed to patients. Therefore, prescribers have the option of allowing these patients to complete their current course of treatment.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving CATENA® should be reported to Santhera or Health Canada.
Santhera Pharmaceuticals Canada Inc.,
1501 McGill College Avenue, 26th floor
Montreal, Quebec H3A 3N9
To correct your mailing address or fax number, contact Santhera
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax
For other health product inquiries related to this communication, contact Health Canada at:
Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
This information and a Questions and Answers document is available on the CATENA® website and on the Health Canada website. Should you have any questions or require additional information, please contact Santhera Medical Information at 1-877-687-8177.
Original signed by
Chief Executive Officer
General Manager, North America