FDA Must Take Action On Sandoz' Omnitrope Application, U.S. District Court says
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency sees three options – appeal, approve or put to a hearing – following the decision which found that FDA had failed to meet its statutory timetable.
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Sandoz' follow-on human growth hormone cleared FDA May 30, but the agancy asserts that the approval does not create a biosimilar regulatory pathway.