FDA to Import Penicillin From France to Address Syphilis Drug Shortage

To address the ongoing U.S. shortages of Bicillin L-A, a drug used to treat syphilis, the FDA has temporarily approved French manufacturer Laboratoires Delbert to import 3.6 million units of Extencilline, (benzathine benzylpenicillin) a drug not approved by the FDA, but also used to treat syphilis.

Importation of unapproved drugs manufactured outside of the U.S. is prohibited by the Food, Drug and Cosmetic Act, however the HHS Secretary may allow temporary importation and distribution of unapproved drugs to alleviate a drug shortage while domestic production gets back up to speed.

The FDA listed a shortage of Bicillin L-A injectable suspension products on April 26, 2023, due to increased demand. Pfizer, manufacturer of Bicillin L-A, sent a letter to its customers in June 2023 estimating second and third quarter 2024 recovery from the shortages.

Read the Laboratoires Delbert clinicians’ letter here.

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