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Access to Clofazimine

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.

The Mechanisms to Obtain Clofazimine

Mechanism 1 (Novartis) – for NTM Patients Not Currently Being Treated Under an Existing Single Patient IND (SPIND) and Who Are Eligible for the Novartis Program:
 
Novartis Pharmaceuticals Corporation is the sponsor of a Clofazimine Expanded Access Program (EAP) in the United States for patients 18 years of age or older with nontuberculous mycobacterial (NTM) infections. This program is intended only for new eligible patients who are not currently being treated under an existing Single Patient IND (SPIND).
 
Patients currently being treated are not eligible for transfer into the Expanded Access program, but treatment under their existing SPIND may continue (see Mechanism 2 below).
 
Physicians who believe that their patient may qualify for the Novartis EAP should contact: Novartis Pharmaceuticals Corporation at 1-888-NOW-NOVA (1-888-669-6682), Monday-Friday, 8:30 am – 5 pm EST Listen for Medical Professionals and press 1, then listen for Medical Information and press 3, then listen for “all other products” and press 2. Any Medical Information Associate can assist with Lamprene/clofazimine inquiries.
 
Please note: Novartis Pharmaceuticals Corporation is not responsible for the content of this webpage or website.
 
Mechanism 2 (FDA) – for Patients Who Are Not Eligible for the Novartis NTM Program:
The healthcare provider goes through their hospital Independent Review Board (IRB) and then submits an individual IND to the FDA for the patient requiring the drug.
 
Required Documents:

  1. FDA Forms:

    1. Form FDA 3926 (PDF) / Form FDA 3926 Instructions OR

    2. Form FDA 1571 (PDF) / Form FDA 1571 Instructions AND Form FDA 1572 (DOC) / Form FDA 1572 Instructions

    3. FDA DAIP Application (DOC)

  2. Doctor’s CV

  3. Current lab results for the patient (CBC, chem, sensitivity data)

  4. Signed informed consent document

  5. 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:

Alison Rodgers

Fax: (301) 796-9887

Email: alison.rodgers@fda.hhs.gov

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.

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