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In Brief: Sanofi

This article was originally published in The Gray Sheet

Executive Summary

Sanofi: Launches Fidia's Hyalgan hyaluronic acid-based knee osteoarthritis treatment product in the U.S. Following FDA approval of Fidia's PMA for Hyalgan May 28, the company submitted a letter to the agency informing it that Sanofi would be the U.S. distributor and making minor editorial changes to the labeling. FDA treated the submission as a PMA supplement, which was approved July 8 ("The Gray Sheet" Aug. 25, p. 10). Sanofi has a separate co-promotion pact with Orthologic for sales to orthopedic surgeons. Priced at $500 per unit, Hyalgan will face competition from Biomatrix' Synvisc HA product, which was approved Aug. 13 and is slated for release this fall ("The Gray Sheet", Aug. 18, p. 6)...

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