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Chemical

Halozyme Completes Manufacturing Probe of Hylenex

August 31, 2010
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The Associated Press reports, Halozyme Therapeutics Inc. has completed an investigation into manufacturing problems behind its Hylenex product and has drawn up a corrective action plan and market relaunch strategy. Hylenex is used to help the body increase the absorption of fluids, in order to boost injected drugs and to increase the absorption of fluids and drugs administered under the skin. The drug was launched in the United States in 2009 for use in pediatric rehydration. In May, Baxter International Inc. voluntarily recalled all lots of Hylenex because of glass particles found in vials of the product. Baxter, based in Deerfield, Ill., makes Hylenex for San Diego-based Halozyme. Baxter said in a separate statement that the problem was caused by an incompatibility between the drug and the glass vial. Halozyme and Baxter are completing materials for a meeting with the Food and Drug Administration over the reintroduction strategy. Halozyme said it has lifted the breach of contract notice it sent Baxter in May.
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