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Amgen Infergen Cleared For Hepatitis C Retreatment Following Relapse

Executive Summary

Amgen's Infergen has expanded its labeling for use in the subsequent treatment of hepatitis C patients who relapse following initial treatment with interferon alfa-2b or Infergen.

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Biologicals Approved In 1999

Product.......... Humate-P (S, V) Ingredient....... Antihemophilic factor/von Willebrand factor complex (human) Sponsor.......... Centeon Pharma GmbH Indication....... New indication for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate Date Approved.... 4/1/1999 Application No... 96-1099 Footnote......... Standard review; Orphan drug

Biologics Approvals Face Orphan Issues In Early 1999; Nine Cleared In 1998

Two FDA decisions about biologics applications in line for early approval in 1999, ReFacto and Rebif, could hinge on orphan exclusivity deliberations.

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

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