US FDA allows import of syphilis drug to address shortages

[January 11, 2024]  (Reuters) -The U.S. Food and Drug Administration will temporarily allow the import of a syphilis drug made by France's Laboratories Delbert, the company said on Wednesday.

Laboratories Delbert said it was coordinating with the health regulator to bring extencilline into the United States to address syphilis drug shortages, according to a letter on the FDA's website.

In June, Pfizer had warned that it would soon run out of supply of its drug, Bicillin L-A, used to treat syphilis and other bacterial infections in children because it has had to prioritize versions made for adults due to a spike in syphilis infections in that population at the time.

Pfizer's penicillin products have been in shortage since April, according to the FDA's website.

According to a survey from August, nearly a third of U.S. hospital pharmacists said that they were forced to ration, delay or cancel treatments as drug shortages in the country approach an all-time high.

Delbert's extencilline, a form of penicillin, is not approved in the United States.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Syphilis is a preventable and curable bacterial sexually transmitted infection (STI) that affected 7.1 million adults between 15 and 49 years old in 2020, according to the World Health Organization

(Reporting by Christy Santhosh in Bengaluru; Editing by Maju Samuel)

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