France's Syphilis Injectable Drug Substitutes During U.S. Shortage

According to a letter by a France-based penicillin producer, the U.S. Food and Drug Administration (FDA) has authorized the importation of an injectable drug to treat syphilis.

A letter dated November 21, 2023, Paris-based from Laboratoires Delbert stated: Temporary Importation of Extencilline (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units with Foreign, non-U.S. Labeling to Address Supply Shortage.

Extencilline will be available in the U.S. only by prescription in 2024.

The FDA's website confirmed this authorization on January 10, 2024.

This change in FDA policy is related to the current penicillin supplier having an available disruption. 

On June 12, 2023, Pfizer notified the FDA that ll Bicillin ® C-R (penicillin G benzathine and penicillin G procaine injectable suspension) are estimated to deplete in Q3 2023 and Bicillin® L-A (penicillin G benzathine injectable suspension) Pediatric (600,000 units/mL) Prefilled Syringes are estimated to deplete by the end of Q2 2023. Furthermore, these penicillin presentations will not be available until further notice.

Key differences between Bicillin® L-A and Extencilline are available at this link.

Neither penicillin injectable drug is a U.S. FDA-approved syphilis vaccine.

The continued prevalence of Syphilis and Congenital Syphilis in the United States highlights the need for a syphilis preventive vaccine, says the World Health Organization.