Naproxcinod FDA 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 timeline for naproxcinod

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

Further information

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