FDA accepts new drug application from Shire's Gattex
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, theof the BritishPharmaceuticals (The Company) (
theFDA) has accepted the supplementarynew drug(sNDA) for Gattex.comthe sNDA application for approval to expand the indications of The Gatex injection for treatment in pediatric patients (1-17 years) who rely on intestinal support for short bowel syndrome (SBS)The FDA is expected to make a review decision in March 2019Gattex is a prescription drug that has previously been approved by the FDA for use in adult patients who rely on intestinal supportData included insNDA includedata from two core, completed Phase III clinical studies (TED-C14-006 and TED-C13-003) and interim data from two ongoing extended studiesin the U.Smarket, Gattex was approved at the end of 2012, making it the first major advance in SBS long-term treatment in nearly 40 yearsThe drug's unique mechanism of action enhances the absorption of the gastrointestinal tractin clinical studies, patients needed an significantly lower volume of intestinal/intravenous (PN/IV) infusions and weekly infusion days compared to baselines, and some patients were even able to get rid of PN/IV support
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