Apricus Biosciences Inc (APRI) Tuesday announced that the U.S. Food and Drug Administration, or the FDA, has granted for its request for Type C regulatory guidance from the agency for MycoVa, the Company's topical treatment for onychomycosis, or nail fungus.
The pharmaceutical company stated that the guidance from the agency for MycoVa is expected to be received in late July 2012. The company further added that 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 in the U.S.
The company stated that the guidance will come from the Division of Dermatology and Dental Products within the Office of New Drugs in FDA's Center for Drug Evaluation & Research.
"This FDA guidance is an integral step in the process of bringing the safe and effective treatment benefits of MycoVa™ to patients suffering from mild to moderate onychomycosis," said Bassam Damaj, PhD, President and Chief Executive Officer of Apricus Bio.
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