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news.King Pharmaceuticals has reported that the FDA has approved revised labeling for its Thrombin-JMI as a result of continuous enhancements the company has made with respect to its manufacturing processes for the product.
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The company said that the revised labeling recognizes the capability of King’s enhanced processes to reduce Factor V light chain content to undetectable levels using currently available methodologies.
The new labeling states: “Thrombin-JMI has been chromatographically purified and further processed by ultrafiltration. Analytical studies demonstrate the current manufacturing process’s capability to remove significant amounts of extraneous proteins, and result in a reduction of Factor Va light chain content levels below the limit of detection of semi-quantitative Western Blot assay (<92 ng/mL, when reconstituted as directed). The clinical significance of these findings is unknown." Craig Paterson, senior director, medical development, King Pharmaceuticals, said: "This new labeling for Thrombin-JMI reflects King's commitment to continually enhance the processes utilized in the manufacture of this product for the benefit of surgeons, healthcare professionals and patients."