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Distribution Changes for Lamprene
As a regular dispenser of Lamprene (clofazimine), you may already be aware that Novartis has joined with the World Health Organization (WHO) to eradicate leprosy. As part of this commitment, we will provide Lamprene free of charge to patients around the world.
In the United States, our partner in this effort is the National Hansen's Disease Programs (NHDP), a unit of the US Department of Health and Human Services, based in Baton Rouge, Louisiana. When US wholesalers, pharmacy chains and individual pharmacies deplete their inventories of Lamprene later this year, the product will no longer be sold in pharmacies and will only be distributed under an Investigational New Drug (IND) application held by NHDP.
Beginning approximately July 1, 2004, or whenever you can no longer acquire Lamprene through your normal supplier, any requests that you receive for Lamprene for the treatment of leprosy should be directed to :
Laboratory Research Branch
Skip Bertman Drive
Baton Rouge, LA 70803
To receive Lamprene for use in the treatment of leprosy, a physician will need to register as an investigator under the IND held by NHDP. Ms. Painter will provide physicians with the necessary paperwork for this process.
In addition, the FDA has requested that Lamprene be available for the treatment of multi-drug resistant tuberculosis (MDRTB). For this purpose, Lamprene will be distributed via single patient INDs administered by the Food and Drug Administration (FDA). All requests for use of Lamprene (clofazimine) for the treatment of MDRTB must be directed to:
Division of Special Pathogen and Immunologic Drug Products (HFD-590)
Center for Drug Evaluation and Research
Food and Drug Administration
Upon Approval of the patient IND, the FDA will request NHDP to distribute Lamprene directly to the Prescriber.
If you have any questions about this process, please contact Novartis at 1-888-NOW-NOVA between 9:00AM and 5:00PM Eastern Standard Time, Monday through Friday
Stephen Cunningham, MD
Vice President and Head
US Clinical Development & Medical Affairs
Novartis Pharmaceuticals Corporation
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