May 31, 2004
Vitrase granted U.S. approval for use as spreading agent in anesthesia
Hyaluronidase will be available commercially in the United States for the first time in 3 years, following announcement of the regulatory approval of Vitrase from Ista Pharmaceuticals.U.S. regulators approved Vitrase (ovine lyophilized hyaluronidase for injection) for use as a spreading agent to help with the dispersion and absorption of other drugs, according to a press release from the product’s marketer.A previously available version of hyaluronidase, the Wyeth drug Wydase, was widely used in ophthalmic anesthesia before it was withdrawn from the market in 2001. A press release from Ista reported that before 2001, Wydase was used as a spreading agent in more than 750,000 ophthalmic surgeries annually.Ista Pharmaceuticals noted in its release that the approval of Vitrase removes hyaluronidase from the Food and Drug Administration’s drug shortage list, where it has been since 2001. Vitrase is highly purified, preservative-free ovine hyaluronidase, according to the release.
Posted by kjalali at May 31, 2004 09:02 PM