FDA approves import of French drug for syphilis amidst wider drug shortages

In a bid to relieve the immediate burden of the ongoing shortage of Pfizer’s syphilis drug, Bicillin L-A (penicillin G benzathine), the US Food and Drug Administration (FDA) has authorized a temporary importation of Laboratoires Delbert’s syphilis treatment, Extencilline (benzathine benzylpenicillin), as per a Reuters report.

The France-based drugmaker’s Extencilline, which inhibits cell wall peptidoglycan during the stage of active bacterial multiplication, is not an FDA-approved treatment. However, a short supply of FDA-approved Bicillin L-A resulted in a collaborative effort between Delbert, Provepharm and its distributor Direct Success. In a letter posted on the FDA’s site on 10 January, Delbert said, effective immediately, Provepharm and Direct Success are the only authorized parties to import and distribute the drug for reconstitution for injection in the US.

As of 10 January, the FDA drug shortages database indicated that Extencilline has an “anticipated availability near term.” In addition, the agency expects the supply shortage to recover in Q2 2024 with Pfizer set to deliver the next batch of Bicillin L-A in April.

In a 12 June 2023 letter, Pfizer said it “prioritized manufacturing capacity” of Bicillin L-A due to the increase in syphilis infection rates and competitive shortages.

While anti-infective Bicillin L-A was first reported to be in shortage by the FDA in April 2023, cancer drugs have also been in shortage, with clinics rationing cancer drug supply and chemotherapy agents being included as one of five drug classes that are most affected by shortages.

A chemotherapy drug like cisplatin is more likely to be in shortage due to its manufacturing specificities and composition, an expert told Pharmaceutical Technology. As of December 2023, the FDA reports that Accord Healthcare has resumed manufacturing injectable cisplatin and is also planning new batches of the product.

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