FDA Denies Approval for New Erectile Dysfunction Medication

The CRL said that the FDA cannot approve the Vitaros NDA in its current form due to problems in Chemistry, Manufacturing, and Control (“CMC”).

From NASDAQ:

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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