Zosano Receives Conditional FDA Acceptance of Proposed Brand Name Qtrypta for M207

- December 12th, 2018

Zosano Pharma (NASDAQ:ZSAN) a clinical-stage biopharmaceutical company, 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. As quoted in the press release: The name Qtrypta (pronounced “kew-trip-tah”) was developed in compliance with the FDA’s Guidance for Industry, Contents … Continued

Zosano Pharma (NASDAQ:ZSAN) a clinical-stage biopharmaceutical company, 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.

As quoted in the press release:

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.”

 

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