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NicOx [FR:COX] awaits Advisory Committee Comments

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NicOx [FR:COX] awaits Advisory Committee Comments PDF Print E-mail
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Sunday, 09 May 2010 14:26

NicOx is a French-based emerging pharmaceutical company with offices in the US. The lead drug for the company, naproxcinod, will be reviewed by FDA Advisory Committees on May 12.

NicOx is a emerging pharmaceutical company headquartered in France and with offices in the US. In September 2009, it submitted an NDA to the FDA for naproxcinod for relief of symptoms associated with osteoarthritis. The FDA accepted the filing and scheduled a PDUFA date of July 24, 2010.

On March 8, the company announced that the FDA would refer the filing to the Arthritis Drugs Advisory and the Drug Safety and Risk Management committees for review. The meeting is scheduled for May 12; however, it is likely that the FDA will post background material on the FDA website tomorrow morning, May 10.

 

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