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Naproxcinod Approval Status

FDA Approved: No
Generic name: naproxcinod
Company: NicOx S.A.
Treatment for: Duchenne Muscular Dystrophy

Naproxcinod is the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase-Inhibiting Nitric Oxide Donators) in development for the treatment of Duchenne Muscular Dystrophy.

Development Status and FDA Approval Process for naproxcinod

DateArticle
Mar 19, 2015Nicox Receives Orphan Drug Designation from FDA for Naproxcinod in Duchenne Muscular Dystrophy
Feb 14, 2014Nicox to re-focus Naproxcinod on Duchenne Muscular Dystrophy
Apr  4, 2012NicOx Provides Update on U.S. Regulatory Status of Naproxcinod
Jul 22, 2010FDA provides Complete Response Letter to NicOx's New Drug Application for naproxcinod
May 13, 2010NicOx provides update on FDA Advisory Committee Meeting for naproxcinod
Mar  8, 2010NicOx announces FDA Advisory Committee to discuss naproxcinod on May 12
Nov 18, 2009NicOx announces FDA accepts naproxcinod NDA for filing
Sep 25, 2009NicOx submits New Drug Application (NDA) for naproxcinod to the US FDA

Further information

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