FDA Announcement on Availability of Extencilline

Dear Partners in Prevention,

We are writing to inform you of the U.S. Food and Drug Administration’s (FDA) announcement about the availability of Extencilline (benzathine benzylpenicillin injection, powder, for suspension) to address the ongoing shortages of Bicillin L-A®. The FDA has exercised enforcement discretion for a temporary importation and use of this treatment temporarily to mitigate the effects of the Bicillin L-A® drug shortage. Extencilline has been determined to be equivalent to Bicillin L-A® and is currently authorized and marketed in other countries.

The FDA has provided distribution and administration information in a letter to healthcare providers (see the “Dear Healthcare Provider Letter”). Please note that the preparation and administration of Extencilline, as well as the contraindications for prescribing, differ from those for Bicillin-LA®. Extencilline will only be available by prescription in the United States. To place an order, please contact Direct Success at Distribution@dsuccess.com or 1-877-404-3338. For additional information related to the product, please contact Provepharm, the U.S. distribution partner, at medicalaffairs@provepharm.com or 610-601-8600.

We understand that you may have questions related to pricing, distribution, and availability, as well as additional clinical concerns. We are working with our federal partners to resolve the programmatic implications of this announcement and will share additional updates as we learn more.

Please continue to refer to the CDC STI Treatment Guidelines on appropriate management, including staging, of syphilis cases. If you need clinical decision-making support, you can contact the STD Clinical Consultation Network.

As we continue to address the ongoing Bicillin L-A® shortage challenges, please refer to the July 2023 letter on priority actions to take during this time.

Thank you for your hard work and commitment to the prevention and control of syphilis.

Sincerely,

Laura Hinkle Bachmann, MD, MPH, FIDSA, FACP
Acting Director
Division of STD Prevention
National Center for HIV, Viral Hepatitis, STD and TB Prevention
Centers for Disease Control and Prevention

Jonathan H. Mermin, MD, MPH
Rear Admiral and Assistant Surgeon General, USPHS
Director
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention
Stay connected: @DrMerminCDC & Connections