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Zosano Receives Conditional FDA Acceptance of Proposed Brand Name Qtrypta™ for M207 | ||
By: Nasdaq / GlobeNewswire - 12 Dec 2018 | Back to overview list |
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FREMONT, Calif., Dec. 12, 2018 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proposed brand name Qtrypta™ for M207, the Company’s investigational drug for treatment of migraine. A request for proprietary name review and final approval for Qtrypta will be included when Zosano submits a New Drug Application (NDA) for M207. The name Qtrypta (pronounced "kew-trip-tah") was developed in compliance with the FDA's Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. The proprietary name development program included research with physicians and pharmacists, and FDA’s conditional approval validated Qtrypta is a proprietary name that is consistent with the FDA's goal of preventing medication errors and potential harm to the public by ensuring that only appropriate proprietary names are approved for use. Final approval of the Qtrypta brand name is conditional on FDA approval of the product candidate, M207. “We are pleased that the FDA has conditionally accepted the name Qtrypta for our lead product candidate,” said John Walker, chairman and chief executive officer of Zosano. “This meaningful step forward aligns with our continued clinical progress as well as preparation for the commercialization of Qtrypta, if approved. The Company has reached a number of milestones in 2018 and we are looking forward to the coming year in which we expect to file an NDA for Qtrypta.” Qtrypta is a novel formulation of zolmitriptan, administered through Zosano’s proprietary Adhesive Dermally-Applied Microneedle System (ADAM™) technology. About Qtrypta (M207) Forward-Looking Statements Zosano Contact: Media Contact: |
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