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Voyageur Pharmaceuticals Completes Milestone with the FDA and Continues to Move Towards Commercialization on Three Fronts
(TheNewswire) Calgary, Alberta – TheNewswire - May 18, 2022:...
About this update from Voyageur Pharmaceuticals Ltd
[{"type":"text","content":"Voyageur Pharmaceuticals Completes Milestone with the FDA and Continues to Move Towards Commercialization on Three Fronts\n \n \n (TheNewswire)\n \n \n \n \n \n \n \n \n \n Calgary, Alberta –\n \n \n TheNewswire -\n \n \n May 18, 2022:\n \n \n Voyageur Pharmaceuticals Ltd.\n \n \n (“\n \n \n Voyageur\n \n \n ” or the “\n \n \n Company\n \n \n ”) (TSXV:VM)\nis pleased to announce that it is progressing with its product\ndevelopment, regulatory pathway and material processing/manufacturing\noperations that could result in revenue generation in Canada this year\nand more importantly revenue generation in the United States early\nnext year.\n \n \n \n \n Product Development\n \n \n \n \n As part of the product development process, Voyageur\nhas recently completed the design and testing of the first batch runs\nof its smoothie product line of barium sulfate contrast agents used\nfor medical CT imaging. Further, the Company is currently working\nthrough the scaled batch requirements for quality control and for\nmeeting various regulatory requirements and specifications.\n \n \n \n \n Once this testing is completed, the data will be used\nto support the initial marketing and sale of the Company’s line of\nbarium sulfate imaging products that are approved for the Canadian\nmarket and in tandem will be used for the Food and  Drug\nAdministration (“\n \n \n FDA\n \n \n ”) submission.\n \n \n \n \n FDA Activity\n \n \n \n \n Based on preliminary discussions with the FDA, Voyageur\nhas submitted extensive documentation for the first barium contrast\nproduct license application.  Voyageur is currently scheduled to meet\nwith the FDA in June, to finalize submission requirements for this\nproduct and once this application is approved, the Company plans on\nsubmitting applications for additional products.\n \n \n \n \n Upon receipt of the application, the FDA may grant the\nlicense within 120 days, thus giving Voyageur the approval to market\nits first barium sulfate contrast agent in the United States.\n \n \n \n \n Voyageur’s plan for revenue generation is close to\nbeing executed, which will support financing and full integration of\nthe Frances Creek project.\n \n \n \n \n Barium\nProcessing/Manufacturing\n \n \n \n \n Voyageur has engaged the engineering firm\n \n \n ...