Phase III primary endpoint met 5/09; trial enrollment completed 11/09 with top-line results expected 1Q2010; positive phase III data reported 2/10, with NDA expected to be filed 2H10; phase III data demonstrate drug is at least as effective as vancomycin (equivalent cure rates) in patients with clostridium difficile infection (4/10)
Brand N/A Generic fidaxomicin
Company name Optimer Product type Non-speciality
Therapeutic category Antiinfectives Key uses Clostridium difficile infection (CDI)
Other Uses N/A Drug Class macrocyclics
Dosage From oral Expected Approval 2011-Q2
FDA Filing N/A Last Update date April 15,2010
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