FDA Approves Importation of French Syphilis Drug Amid U.S. Shortage

The move comes as syphilis cases surge, with newborn infections rising over 203% between 2017 and 2021.

The U.S. Food and Drug Administration (FDA) has approved the temporary importation of 3.5 million units of Extencilline, a syphilis drug from French company Laboratoires Delbert, amid an ongoing shortage of the first-line treatment for syphilis in the United States.
The imported drug, not currently approved in the U.S., is similar to Bicillin, a long-acting injectable form of penicillin made by Pfizer, which has been in short supply since mid-2023.
Bicillin is the recommended treatment for syphilis in adults and the only recommended treatment for pregnant women to prevent the transmission of syphilis from mother to newborn.
The FDA's decision was applauded by the National Coalition of STD Directors, who have been urging the administration to address the Bicillin shortage as syphilis cases have surged across the country.
Syphilis cases in the U.S. have increased by about 74% between 2017 and 2021, with cases of syphilis in newborns rising more than 203%.