FDAnews
www.fdanews.com/articles/126584-fda-issues-communication-regarding-giazo-nda

FDA Issues Communication Regarding Giazo NDA

April 28, 2010
Salix Pharmaceuticals Wednesday announced the FDA has issued a complete response letter regarding the New Drug Application (NDA) for Giazo (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.
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