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 OCTOBER 2018: The following information applies to requests for new and established FDA authorized single patient investigational new drug (SPINDs) for clofazimine. The process for receiving clofazimine under the Novartis Expanded Access Non-Tuberculous Mycobacterium (NTM) IND has not changed.
Effective October 1, 2018, the National Hansen’s Foundation will no longer be distributing Lamprene/clofazimine for your SPIND patient(s). Novartis Pharmaceuticals will be the distributor of drug for your SPIND patients.
PROCESS TO RECEIVE CLOFAZIMINE:
The process for requesting an SPIND# from the FDA has not changed [see below]. What has changed is as follows.
NOVARTIS WILL REQUEST THE FOLLOWING:
SHIPPING LABEL: You will no longer be required to supply a prepaid UPS label for shipment. Novartis will ship the drug to you from their account.
Options for requesting access to Clofazimine
OPTION #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 Option #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.
Option #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.
FDA will review the information submitted and determine if an SPIND will be issued. If issued, physician will receive from FDA, via email, the SPIND# and a copy of the SPIND Acknowledgement Letter. The physician should then follow the steps above under “PROCESS TO RECEIVE CLOFAZIMINE“.