Zosano Pharma Announces FDA Acceptance of 505(b)(2) New Drug Application for Qtrypta™ for the Acute Treatment of Migraine
Zosano Pharma Corporation (ZSAN)
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Source: GlobeNewswire
FREMONT, Calif., March 04, 2020 (GLOBE NEWSWIRE) -- Zosano Pharma Corporation (Nasdaq: ZSAN), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Qtrypta™ for filing and substantive review. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of Qtrypta™ is set for October 20, 2020. This date reflects a standard 10-month review period and is consistent with the review timeline for a 505(b)(2) NDA submission. “The FDA’s filing of our NDA represents a significant milestone and an important step for Zosano and Qtrypta toward our goal of bringing an innovative therapy that we believe can make an important difference in the lives of patients who suffer from migraine. We believe Qtrypta, if approved, has the potential to offer patients rapid, sustained pain relief with no recurrence,” said Steven Lo, President and Chief Executive Officer of Zosano. “This su
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