FDA Says Medicis' (MRX) 510(k) Application to Market LIPOSONIX Does Not Provide Sufficient Data
According to a Form 8-K filing from Medicis (NYSE: MRX), the FDA has issued a letter to the company notifying it that data presented in the 510(k) application to market its LIPOSONIX system in the U.S. were not sufficient to support a finding of substantial equivalence without additional information in a new submission.
The FDA provided general guidance in the letter on the additional information that would be needed to support 510(k) clearance. The Company believes it has additional data and analyses that are responsive to the FDA’s guidance, and will actively pursue a meeting with the FDA to clarify the next steps. The FDA did not request in its letter any specific safety data or additional analysis of the existing safety data. The Company notes that the primary endpoint of the clinical trial, as agreed to with the FDA prior to the start of the trial, was achieved.
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