Access to Ferriprox

This notice has been prepared in response to requests in the United States of America regarding the availability of Ferriprox™ (deferiprone) to treat iron overload in thalassemia patients prior to marketing approval in this country.

Although Ferriprox has been approved in certain countries Apotex has not yet filed a new drug submission with the FDA for approval in the USA. For those patients in the United States for whom deferiprone is required prior to its approval by the FDA, as judged by their physician, access to the medication may be sought via a Treatment Investigational New Drug (IND) Application with the FDA, using the following procedure:

1.      The patient’s physician should contact Apotex at the address below.  Apotex will provide the physician with the appropriate information on Ferriprox.

2.      The physician must contact the FDA, which will review the application, and upon approval, the FDA will issue an IND number.  The agency will contact the applying physician, by phone or fax, followed by a letter.  The IND is considered active upon issuance of the number.

3.   Upon receipt of the notification, the physician will provide Apotex with the IND number, enabling Apotex to supply deferiprone for treatment of the patient specified in the request.

There are other requirements of the treating physician, including those related to Investigational Review Board Requirements and Patient Consent.  The physician is advised to refer to the Code of Federal Regulations pertaining to these matters (21CFR Part 312.35)

For further information, please contact the

Ferriprox Information line at Apotex

1-866-927-6337 or email ferriprox@apotex.com