Apricus Biosciences (APRI) Granted Regulatory Guidance With FDA for MycoVa(TM) for the Treatment of Onychomycosis
5/22/2012 9:29:14 AM
SAN DIEGO, May 22, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that the United States ("U.S.") Food and Drug Administration ("FDA") has granted the Company's request for Type C regulatory guidance from the agency for MycoVa™, the Company's topical treatment for onychomycosis, or nail fungus. The guidance is expected to be received in late July 2012. The purpose of the requested guidance is to obtain feedback from the agency regarding the suitability of MycoVa™'s clinical and safety data to support a New Drug Approval ("NDA") in the U.S.
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