KemPharm Says It Filed NDA Amendment Request With FDA For Apadaz
KemPharm, Inc. (NASDAQ: KMPH) revealed that it filed with the Food and Drug Administration an amendment request to its New Drug Application (NDA) for its Apadaz (benzhydrocodone hydrochloride and acetaminophen). This is an investigational abuse-deterrent product candidate for the short-term management of acute pain.
KemPharm said the amendment was focused on offering the FDA additional information the company seeks to include in the FDA's current review of the Apadaz NDA. The company indicated the regulator was reviewing the request and their determination is anticipated to impact the previously announced target action date for Apadaz of June 9 set by the FDA under the Prescription Drug User Fee Act.
The company's president and CEO, Travis Mickle, commented, "While the FDA's provided us with a draft label, we feel that additional information could strengthen the draft, with a focus on the section relating to abuse-deterrent product labeling. Our discussions with the FDA have been constructive and we are hopeful that we can agree on an approval pathway that includes abuse-deterrent labeling for Apadaz."
In the pre-market on Thursday, the stock traded down 12.8 percent at $6.30.
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