FDA Not Following Up On Follow-On, Sandoz Says
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA has not yet communicated to Sandoz any timeline for completing market authorization for the follow-on biologic Omnitrope (recombinant human growth hormone), in spite of a federal judge's ruling stipulating the agency make a decision
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FDA has not yet communicated to Sandoz any timeline for completing market authorization for the follow-on biologic Omnitrope (recombinant human growth hormone), in spite of a federal judge's ruling stipulating the agency make a decision. Sandoz said it is still waiting to hear from FDA following the April 10 court ruling and that there is no indication yet on when the company will hear anything. Washington, D.C. Federal Judge Robert Urbina ruled that FDA must decide whether to approve or reject the marketing application for the follow-on biologic, but did not set a timeline for FDA to follow (1 (Also see "FDA Must Take Action On Sandoz' Omnitrope Application, U.S. District Court says" - Pink Sheet, 13 Apr, 2006.)). The product is launching in the EU following a favorable European Commission decision (see 2 (Also see "Omnitrope Gains Final EU Approval" - Pink Sheet, 18 Apr, 2006.) ). -Todd Leeuwenburgh |