SAN DIEGO (AP) — Halozyme Therapeutics Inc. has completed an investigation into manufacturing problems behind its Hylenex product and has drawn up a corrective action plan and strategy to reintroduce it to the market.
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.
To date, no adverse medical events have been reported in connection with the withdrawn Hylenex product.
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 notice it sent Baxter in May.
