Contrast maker Berlex Imaging notified customers that it has suspended production of peptide-based radiopharmaceutical NeoTect until it resolves quality control issues at its European plant.
The decision to suspend sales was an internal company decision and was not due to any regulatory action, according to Berlex product information specialist Nancy Robertson at the company’s Wayne, NJ, headquarters.
"It’s the need to reconcile differences in quality control testing parameters between Europe and the U.S.," Robertson said, adding that Berlex is working with the "appropriate agencies" to resolve the matter.
"Some of the quality assurance tests they do in Europe are not as rigid as what we have to do here in the U.S., so in order to fix that, we decided to suspend production until they could get all those quality tests resolved," she said.
NeoTect is manufactured exclusively in Europe, where Berlex is a subsidiary of German drug giant Schering. Robertson said that "a couple of the batches had failed QC in the U.S., according to NDA (new drug approval) standards."
NeoTect [technetium Tc-99m-labeled depreotide] was first marketed in the U.S. in August 1999 by Londonderry, NH-based Diatide, now part of Berlex. At that time, peptide-based radiotracers were considered the optimum means of imaging certain tumors, but FDG-PET has become more popular as it is regarded as cheaper, and PET images are easier to read.
There is no problem with the efficacy or the safety of the drug, Robertson said, adding that NeoTect manufacturing and sales are unlikely to resume until the beginning of 2004.
By Robert BruceAuntMinnie.com contributing writer
March 28, 2003
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