On February 10, 2016, KemPharm, Inc., a Delaware corporation, or KemPharm, issued a press release announcing that its new drug application, or NDA, for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration, or the FDA. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and is not incorporated by reference into any of KemPharm’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01 Other Events.
As described above, on February 10, 2016, KemPharm announced that its NDA for KP201/APAP has been accepted and granted priority review by the FDA. In addition, the FDA has set a target action date under the Prescription Drug User Fee Act of June 9, 2016.
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