This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|April 16, 2014
GSK Receives FDA Approval for Tanzeum
Author(s)Pharmaceutical Technology Editors
GSK receives FDA approval of Tanzeum for adults with type 2 diabetes.
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The FDA approval of albiglutide is based on the results of GSK’s Phase III Harmony program, consisting of eight trials and involving over 5000 patients, 2000 of which were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatments, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment.
GSK expects to launch Tanzeum in the third quarter of 2014.
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