Dear Colleague Letters
Rifampin Availability and Discontinuation of Sanofi-Aventis Rifampin Products
August 19, 2020
Dear Colleague:
On June 15, 2020, the U.S. Food and Drug Administration (FDA) posted information regarding the permanent discontinuation of three Sanofi-Aventis rifampin products: Rifadin® (rifampin 150 mg and 300 mg capsules); Rifamate® (a fixed-drug combination of isoniazid and rifampin), and Rifater® (a fixed-drug combination of isoniazid, rifampin, and pyrazinamide). Rifampin is a core drug in the standard regimens for drug-susceptible and isoniazid-resistant active tuberculosis (TB) and latent tuberculosis infection. Currently, FDA is determining the status of rifampin from other manufacturers.
We recommend that you assess your rifampin availability with your pharmacy, your suppliers, or both. If you find any potential problems, please update the CDC project officer for your jurisdiction’s TB cooperative agreement by e-mail message or telephone. In addition, if you find a shortage or if you are forecasting a shortage, please notify FDA directly by e-mail (drugshortages@fda.hhs.gov) or telephone (240-402-7770). You can report a shortage to the National Tuberculosis Controllers Association (NTCA) with a form that is featured on the Association’s home page, http://www.tbcontrollers.org/external icon.
We do not have a timeline yet for updated information about rifampin. We will alert you to changes as we learn of them. You can check on the publicly available notifications of drug shortages and discontinuations at https://www.accessdata.fda.gov/scripts/drugshortages/default.cfmexternal icon. Please contact your cooperative agreement project officer with any other questions.
Yours truly,
Terry
Terence Chorba, MD, DSc
Chief, Field Services Branch, Division of Tuberculosis Elimination
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
1600 Clifton Road NE (US 12-4), Atlanta, GA 30329