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In its lawsuit, the OFA said that the FDAs decision to end the shortage was a reckless and arbitrary move and could deprive patients of a vital treatment for type 2 diabetes and obesity. In an interview with BioSpace last month, David Rosen, partner at Foley & Lardner, said that the lawsuit is a precedent in this area. Prior to the OFA suit, no one has ever challenged the FDAs decision to remove a therapy from the drug shortage list. The OFA case is still ongoing, with the next court update due on Thursday
Injectable drugs also require sterile production , highly controlled formulation, and consistent dosing
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Lloyd MD, Darley DJ, Wierzbicki AS, Threadgill MD
