CATENA® (idebenone) - Voluntary withdrawal of CATENA® from the Canadian market - For the Public

Starting date:

February 27, 2013

Posting date:

February 27, 2013

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product withdrawal

Audience:

General Public

Identification number:

RA-23519

This is duplicated text of a letter from Santhera Pharmaceuticals Canada Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication - Health Canada Endorsed Important Information on CATENA^® (idebenone)

February 27, 2013

Dear CATENA^® Patient,

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 that CATENA^® will no longer be sold in Canada as of April 30, 2013.

• CATENA^® is being voluntarily withdrawn from the market as of April 30, 2013.
• The withdrawal of CATENA^® is due to the failure to confirm the drug’s benefits in additional studies and is not the result of a specific safety concern.
• Patients and their caregivers are advised to contact their doctor to discuss alternative treatment options before April 30, 2013.

Catena was originally authorized with conditions in Canada. Authorization with conditions means that Santhera had to do more studies to confirm that CATENA^® was safe and effective in the treatment of Friedreich's Ataxia. However, the data from additional studies did not provide that confirmation of effectiveness. As a result, Santhera has agreed to voluntarily withdraw CATENA^® from the market in Canada.

No specific safety issues have prompted this action.

If you are taking CATENA^®, please contact your doctor and/or pharmacist to discuss your treatment options before April 30, 2013, as no prescriptions will be filled after close of business on this date.

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

Phone: 1-877-687-8177

You can report any suspected side effect 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)

E-mail: bcans_enquiries@hc-sc.gc.ca

Telephone: 613-941-1499

Fax: 613-941-1668

Information 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

Thomas Meier

Chief Executive Officer

William Richmond

General Manager, North America