Lamprene (generic name clofazimine) manufactured by Novartis, is FDA approved for the treatment of leprosy, but has not been available through traditional pharmaceutical distribution since 2004. The safety and effectiveness of Lamprene for the treatment of other nontuberculous mycobacterial (NTM) infections has not been established.
Updated Information as of January 2017: There are now two mechanisms to obtain clofazimine for the treatment of NTM infections when the potential benefit justifies the potential risks. The following content provides instructions for physicians to obtain clofazimine via these two mechanisms.
Current lab results for the patient (CBC, chem, sensitivity data)
Signed informed consent document
Pre-paid UPS or FedEx shipping label
You do not need to contact Novartis.
Once you have gone through the IRB and sent your forms and label to the FDA and you are approved, the clofazimine will be sent to your office through Hansen’s National Disease Center Pharmacy – it usually takes about 10-14 days from the time the FDA receives your email/fax to when the clofazimine arrives.
Fax or Email the Forms to:
Fax: (301) 796-9887
If you have additional questions, please contact the FDA at the following number: Alison Rodgers, 301-796-0797 or Division of Anti-Infective Products main number, 301-796-1400.