'FDA Allows Importing Unapproved Syphilis Treatment Amid Shortage Of Pfizer Antibiotic'

 The FDA is working with a French drugmaker, Laboratoires Delbert, to temporarily allow the import of syphilis treatment amid an ongoing shortage.

In a letter on Wednesday, Delbert said that it's working with the FDA to temporarily import 3.5 million units of Extencilline, which is not approved in the U.S. 

It's similar to Bicillin, a long-acting injectable form of the antibiotic penicillin made by Pfizer Inc 

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 that has been in short supply since the middle of last year. 

The shortage is estimated to last through June, according to the FDA.

Unlike Pfizer's prefilled syringe, Laboratoires Delbert's drug formulation is a powder that must be mixed and injected by a health-care provider.

Citing Pfizer spokesperson, Bloomberg noted that to fix the shortage, the U.S. pharma giant has added manufacturing shifts and more than halved production time. 

The company has invited customers who are having trouble getting the drug to contact them directly. "We continue to supply the market above historical rates, and we are reserving product for emergency needs," the spokesperson said.

Effective immediately, Provepharm will distribute the following presentations of Extencilline, (benzathine benzylpenicillin) Powder and diluent for reconstitution for injection, 1,200,000 units and 2,400,000 units.

From 2017 to 2021, reported cases of syphilis in the U.S. jumped about 74%, and cases of congenital syphilis increased by more than 203%, CNN noted, citing data from the US Centers for Disease Control and Prevention. 

More than 3,700 babies were born with syphilis in the U.S. in 2022, a rise of more than 1,000% from 2012 and the highest in more than 30 years.

https://www.benzinga.com/general/biotech/24/01/36594393/fda-allows-importing-unapproved-but-essential-syphilis-treatment-amid-shortage-of-pfizers-antibio