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Drug Evaluation & Research

CDERNEW-TEXT 9/17/2007


Tuesday, September 18, 2007

September 17, 2007

Drug Shortage; Drug to be Discontinued; Ethmozine (moricizine
hydrochloride) 200mg, 250g, and 300mg tablets
http://www.fda.gov/cder/drug/shortages/default.htm#Ethmozine (updated)

FDA issues an Alert on the risk of QT prolongation and Torsades de
Pointes (TdP) in patients treated with Haldol (haloperidol). Drug
Information http://www.fda.gov/cder/drug/InfoSheets/HCP/haloperidol.htm


New PDUFA payment procedures for application and supplement fees
effective October 1, 2007
http://www.fda.gov/cder/pdufa/application_fees.htm#new


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posted by Mags @ 2:04 PM,




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