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Friday, August 19, 2011
NPS Pharmaceuticals Inc., of Bedminster, N.J., submitted the chemistry, manufacturing and controls section of its new drug application (NDA) for Gattex (teduglutide), a recombinant analogue of human glucagon-like peptide 2, for use in short bowel syndrome (SBS). The rolling NDA follows positive data from a 24-week Phase III study testing Gattex's ability to reduce parenteral nutrition and intravenous fluid requirements in adults with SBS.

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