KemPharm Receives Day-74 Letter for KP415 NDA
KemPharm, Inc. (KMPH)
Last kempharm, inc. earnings: 2/28 07:30 am
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Source: GlobeNewswire
FDA Sets PDUFA Date of March 2, 2021 CELEBRATION, Fla., May 19, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the Company has received a filing communication from the U.S. Food and Drug Administration (FDA), commonly known as the “Day-74 Letter.” The Day-74 Letter stated that the New Drug Application (NDA) for KP415 is sufficiently complete to permit a substantive review by the FDA, and that the target goal date under the Prescription Drug User Fee Act (PDUFA) is March 2, 2021. In addition, the Day-74 Letter indicated that the FDA is not currently planning to hold an advisory committee to discuss the KP415 NDA. “As expected, the FDA has set the PDUFA date for March 2, 2021, and we are pleased that the regulatory process is proceeding based on the promulgated timeframes,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “This is another
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