CDERNEW-TEXT 9/26 & 27/2007
Thursday, September 27, 2007
September 27, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Abilify (aripiprazole) Tablets, Otsuka, Labeling Revision
Abilify (aripiprazole) DISCMELT, Otsuka, Labeling Revision
Abilify (aripiprazole) Oral Solution, Otsuka, Labeling Revision
Abilify (aripiprazole) Intramuscular Injection, Otsuka, Labeling
Revision
Albuterol Sulfate Inhalation Solution, Watson Labs, Approval
Gabapentin Capsules, Hikma Pharma, Approval
KALETRA (lopinavir/ritonavir) Tablets, Abbott Labs, Labeling Revision
KALETRA (lopinavir/ritonavir) Oral Solution, Abbott Labs, Labeling
Revision
Methimazole Tablets, Caraco Pharma, Approval
Symlin (pramlintide acetate) Injection, Amylin Pharma, Package Change
Zebeta (bisoprolol fumarate) Tablets, Duramed Pharma, Labeling Revision
Ziac (bisoprolol fumarate and hydrochlorothiazide) Tablets, Duramed
Pharma, Labeling Revision
September 26, 2007
Drug Safety Oversight Board meeting, 8/22/2007; public summary
http://www.fda.gov/cder/drug/DrugSafety/DSOBmeetings/DSOB20070822.htm
Drug Shortage: Indocyanine Green for Injection, USP (IC-GREEN)
http://www.fda.gov/cder/drug/shortages/default.htm#Indocyanine (updated)
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
FDA issues a Public Health Advisory and Healthcare Professional Sheet
for Fentora (fentanyl buccal tablets). Drug Information
http://www.fda.gov/cder/drug/infopage/fentanyl_buccal/default.htm
Office of Generic Drugs - News and Announcements Section
http://www.fda.gov/cder/ogd/index.htm#new
(updated)
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posted by Mags @ 4:46 PM,
