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FDA allows import of second antibiotic to treat syphilis during Bicillin shortage

July 18, 2024

Editor’s note: For more coverage of drug, immunization and medical device shortages, visit https://bit.ly/AAPNewsDrugShortages.

The Food and Drug Administration (FDA) is allowing the temporary importation of a second antibiotic to treat syphilis while there is a shortage of Bicillin L-A (penicillin G benzathine injectable suspension).

Lentocilin (benzathine benzylpenicillin tetrahydrate) is a powder and diluent for suspension for injection and is available in a strength of 1.2 million units. The product is manufactured by Laboratórios Atral in Portugal and distributed by the Mark Cuban Cost Plus Drug Company. It is not FDA approved.

Several differences between the warning and instructional labels for Lentocilin and Bicillin L-A are detailed in a letter from Laboratórios Atral to health care providers.

Bicillin is used to treat pregnant women with syphilis, which helps protect their babies from the disease. Bicillin also is used to treat babies with congenital syphilis, which has been on the rise.

Pfizer sent a letter to customers in June 2023 about supply issues impacting Bicillin L-A and Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) prefilled syringes. Some presentations remain in limited supply and others are depleted, according to Pfizer.

Since November 2023, the FDA has been allowing the temporary importation of Extencilline (benzathine benzylpenicillin) from Laboratoires Delbert in conjunction with Provepharm Inc. and Direct Success Inc. The product is marketed in France and manufactured in Italy.

To place an order for Lentocilin, contact TopRx at [email protected] or 800-542-8677.

 

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