CDERNEW-TEXT 9/28/2007
Friday, September 28, 2007
September 28, 2007
The Food and Drug Administration Amendments Act of 2007 is signed into
law http://www.fda.gov/oc/initiatives/advance/fdaaa.html
The Act http://www.fda.gov/oc/initiatives/HR3580.pdf
PDF
http://www.fda.gov/cder/graphics/pdf.gif
FDA takes action to stop marketing of unapproved hydrocodone products
http://www.fda.gov/cder/drug/unapproved_drugs/enforcement.htm
Manufacturers of gadolinium-based contrast agents for magnetic resonance
imaging issue a Dear Healthcare Professional Letter
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Gadolinium
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Actoplus Met (pioglitazone HCl and metformin HCl) fixed-dose combination
Tablets, Takeda Global, Labeling Revision
DUETACT (pioglitazone HCl plus glimepiride) fixed-dose combination
Tablets, Takeda Global, Labeling Revision
KALETRA (lopinavir/ritonavir) Capsules, Abbott Labs, Labeling Revision
Lamivudine Tablets, Aurobindo Pharma, Tentative Approval
Lipitor (atorvastatin calcium) Tablets, Pfizer Inc., Labeling Revision
Naftin Gel (naftifine hydrochloride 1%), Merz Pharma, Package Change
STROMECTOL (ivermectin) Tablets, Merck & Co., Labeling Revision
Prescription Drug User Fee Act (PDUFA) Billable Products
http://www.fda.gov/cder/biologics/pdufa/billable.pdf
PDF
http://www.fda.gov/cder/graphics/pdf.gif (updated)
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posted by Mags @ 6:47 PM,
