Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration (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.
In this complete response letter there are no requests for new pre-clinical or clinical trials. The sole issue raised in this letter concerns a deficiency of the manufacturing facility for this application. The manufacturer has responded to the FDA and continues to work with the FDA to resolve the matter. The facility only manufactures COLAZAL® Capsules and GIAZO™ Tablets for Salix.
Salix Pharmaceuticals, Ltd.,