FDA clears penicillin imports from French drugmaker amid Pfizer shortage
11 Jan 2024
Drug Approval
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Source: FiercePharma
The French drugmaker is working with the FDA to bring in shipments of its Extencilline to the U.S. The product, while not approved in the U.S., is made up of penicillin G benzathine (or benzathine benzylpenicillin), which Pfizer has branded as Bicillin.
In a letter (PDF) published by the FDA, Laboratoires Delbert noted that it will import 1,200,000 units of its powdered Extencilline and 2,400,000 units of the diluent version for reconstitution for injection. The meds are manufactured in Italy and both lots have an expiration date of 2025.
Bicillin is used for an array of bacterial infections such as strep throat, but it's the preferred treatment for syphilis and gonorrhea.
The FDA first reported a shortage of the treatment in April. In June, Pfizer updated its hospital customers on the supply interruption, attributing the supply shortfall to a “complex combination of factors” including a spike in demand. In its letter, Pfizer said it had prioritized its Bicillin manufacturing capacity and that its supplies would dwindle throughout the year.
At the time, Pfizer estimated that four of its combination doses would be back in stock by mid-2024. The company is the only U.S. supplier of penicillin G benzathine injections.
In response to the shortage, the Centers for Disease Control and Prevention (CDC)’s division of STD prevention recommended mitigation strategies be employed by healthcare providers, including discouraging Bicillin use for other infectious diseases.
Last April, the CDC reported a nearly 32% jump in syphilis cases from 2020 to 2021 and a 203% rise over the last five years. The recent spike could be a continuation of disruptions in STD screenings over the COVID-19 pandemic, according to the agency.
A more recent CDC report found that more than 3,700 babies were born with syphilis in 2022, representing a tenfold increase since 2012. Almost nine in ten cases of newborn syphilis could have been prevented with timely testing and treatment.
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