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Approval In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Halozyme's Hylenex is NME: Recombinant human hyaluronidase (formerly Enhanze SC) spreading agent is approved Dec. 2 as a new molecular entity via the 505(b)(2) pathway, entering an increasingly crowded hyaluronidase market. FDA is considering all hyaluronidase products to be NMEs because of the lack of characterization. Hylenex, which will be marketed by Baxter, is indicated "as an adjuvant to increase the absorption and dispersion of other injected drugs, for hypodermoclysis and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents." PrimaPharm's bovine-derived hyaluronidase Hydase was approved Oct. 25, while Amphastar's bovine-derived Amphadase and Ista's ovine-derived Vitrase were both approved in 2004. All four of the approved agents received priority reviews (Pharmaceutical Approvals Monthly November 2005, p. 14)...
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