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Executive Summary

MARSAM WILL SHIP PENICILLIN G SODIUM DIRECTLY TO HOSPITALS upon request, following discontinuation of bulk material from the firm's supplier. Instead of selling through wholesalers, the generic injectables company will sell direct to hospitals and physicians, which require the antibiotic for patients who are intolerant to penicillin G potassium. Marsam said it is working with FDA on ways to communicate the limited supply situation. While there are many manufacturers of penicillin G potassium, Marsam is the only U.S. marketer of the sodium version of the product. Glaxo was the only approved supplier of bulk penicillin G sodium in the U.S. until it sold its penicillin facility in the U.K. to Synpak in 1991. Synpak apparently decided to stop manufacture of bulk penicillin recently. When Marsam found out its supplier would no longer be manufacturing the raw material, Marsam said it asked for extra quantities of the material before the supplier ceased production. Marsam has about two months of product on hand. Marsam has found a new supplier for the sodium penicillin raw material. However, the company would be required to submit a supplemental AADA for a change of raw material sources. The Austrian firm Biochemie GmbH received an antibiotic approval for its sterile bulk penicillin G sodium in April ("Tbe Pink Sheet" May 31, T&G-12) and would be a possible source of raw material; however, Biochemie's product would require buffering to be equivalent to the bulk material Marsam was using. FDA is likely to give an application a priority review because of the implications of a shortage of penicillin G sodium.

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