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APRI > SEC Filings for APRI > Form 8-K on 19-Dec-2013All Recent SEC Filings

Show all filings for APRICUS BIOSCIENCES, INC.



Other Events

Item 8.01 Other Events.

On December 19, 2013, Apricus Biosciences, Inc. (the "Company") issued a press release announcing that France's National Agency for Medicines and Health Products Safety (ANSM) has granted national phase approval to Vitaros®, indicated for the treatment of patients with erectile dysfunction. The Company has now received a total of seven national phase approvals for Vitaros®, including France, Germany, Ireland, Italy, the Netherlands, Sweden and the United Kingdom following its broad approval by European health authorities in June 2013.

As previously announced in a press release issued on August 29, 2013, Swissmedic, the Agency for Therapeutic Products in Switzerland, recommended against approval of marketing authorization in Switzerland for Vitaros® for the treatment of erectile dysfunction. The Company submitted an appeal of the decision. Subsequently, the Company was notified by the Court that Swissmedic had offered to suspend the appeal and withdraw its decision rejecting Vitaros®. The Company has agreed to this and is waiting for confirmation from the Court. Once accepted, Swissmedic will issue a new decision on the approvability of the application. As such, there can be no assurance that Swissmedic will approve the application. The Company currently expects that it will provide an announcement updating the status of this application no later than with the filing of the Company's Annual Report on Form 10­K for the year ending December 31, 2013.

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