Apricus Biosciences (NASDAQ: APRI) this morning said that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of its recently resubmitted New Drug Application (NDA) for Vitaros™ and considers it a complete, class 2 response to Apricus’ 2008 action letter. Additionally, the PDUFA (Prescription Drug User Fee Act) goal date for conclusion of the FDA’s review is set for the standard review period for NDA resubmissions of six months, falling on February 17, 2018. “The FDA has determined that the resubmission is a complete, class 2 response to our 2008 action letter. Importantly, we believe that Vitaros, if approved, will address a significant unmet need in the erectile dysfunction market,” Apricus chief executive officer Richard W. Pascoe stated in the news release.
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About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus has two product candidates currently in development. Vitaros is a product candidate in the United States for the treatment of erectile dysfunction, which is in-licensed from Warner Chilcott Company, Inc., now a subsidiary of Allergan plc (Allergan). RayVa is the company’s product candidate in phase 2 development for the treatment of the circulatory disorder Raynaud’s phenomenon, secondary to scleroderma, for which the company owns worldwide rights. For further information on Apricus, visit www.apricusbio.com.
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