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8/14/2000

New Source Found for Sterile Floxuridine

Cheryl A. Thompson

Sterile floxuridine for injection, unavailable from Roche Laboratories Inc. since January, can be obtained on an emergency basis from Bedford Laboratories as of May 15. The company said normal distribution will ensue when the supply can meet market demand. [On May 16, the company said the product can be obtained on a nonemergency basis, including for use in ongoing clinical trials.]

Bedford had already sought approval from the Food and Drug Administration (FDA) for the company's generic floxuridine injection when Roche announced that it could not supply sterile product. Originally expecting its generic product to garner 30 percent of the floxuridine market, Bedford had bought only enough bulk product from its Michigan supplier to meet the anticipated demand, said Joe Marchese, director of marketing and customer operations. 

"We're begging and pleading with our raw material supplier to scale up production," said Marchese, who will field requests for the product. The company's decision to allocate vials of sterile floxuridine injection on a medical emergency basis stems strictly from this lack of raw material, he said. 

The problem at Roche is related to manufacturing, not lack of raw material. According to a document marked "confidential" on the company's Web site, batches of simulation floxuridine product "did not meet pre-established acceptance criteria." FDA requires that drug manufacturers test their production lines with simulation batches. 

Floxuridine's labeling states that the drug is used in the palliative management of gastrointestinal adenocarcinoma that has metastasized to the liver. 

Marchese can be reached at 440-232-3320, extension 369.

[Marchese said May 16 that Bedford "will try to accommodate people's requests as best as possible." Its supplier has scaled up production of the raw material, and Bedford's supplies of sterile floxuridine injection should be stronger by the middle of June.]