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FDA Denies Approval for New Erectile Dysfunction Medication
RTTNews.com) – Apricus Biosciences Inc. ( APRI ) said that the U.S. Food and Drug Administration has issued a complete response letter or “CRL” for the New Drug Application (“NDA”) of Vitaros or alprostadil, DDAIP.HCl, a topical cream for the treatment of erectile dysfunction.
The CRL indicated that the FDA cannot approve the NDA for Vitaros in its present form, identifying deficiencies related to Chemistry, Manufacturing and Control (“CMC”) and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.
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