September 9, 2024 Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC)
Рет қаралды 2,290
Күн бұрынThe Committee will discuss new drug application (NDA) 213972, for oral sulopenem etzadroxil/probenecid tablets consisting of 500 mg sulopenem etzadroxil and 500 mg probenecid, submitted by Iterum Therapeutics US Limited, for the proposed indication of treatment of uncomplicated urinary tract infections (uUTIs) caused by designated susceptible bacteria in adult women 18 years of age and older.
U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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MineCZ
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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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U.S. Food and Drug Administration
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FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory...
U.S. Food and Drug Administration
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Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic aci...
U.S. Food and Drug Administration
Рет қаралды 343
U.S. Food and Drug Administration
Рет қаралды 1,3 М.