KemPharm (KMPH) Begins FDRR Process to Appeal FDA Complete Response Letter on Apadaz
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KemPharm Appeals FDA Complete Response Letter on Apadaz™ by Initiating a Formal Dispute Resolution Process
November 3, 2016 7:30 AM EDTCORALVILLE, Iowa, Nov. 03, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced it has appealed the Food and Drug Administration's (FDA) Complete Response Letter (CRL) for Apadaz (benzhydrocodone and acetaminophen) through the initiation of the Formal Dispute Resolution Request (FDRR) process. Apadaz is KemPharms investigational product candidate that is intended to provide short-term management of acute pain in a product with abuse-deterrent attributes.
The CRL was received in response to the KemPharm submission of a new drug... More