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,
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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,
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CDERNEW-TEXT 9/24 - 25/2007
Wednesday, September 26, 2007
September 25, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Anzemet (dolasetron mesylate) Tablets, Sanofi-Aventis, Labeling Revision
Anzemet (dolasetron mesylate) Injection, Sanofi-Aventis, Labeling
Revision
HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350 sodium
bicarbonate & potassium chloride), Braintree Labs, New Dosage Regimen
Ofloxacin Otic Solution, Bausch & Lomb Inc., Tentative Approval
TussiCaps (Hydrocodone polistirex & Chlorpheniramine polistirex)
Extended-Release Capsules, Mallinckrodt Inc., Approval
September 24, 2007
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
BuSpar (buspirone HCl) Tablets, Bristol-Myers Squibb, Labeling Revision
CellCept (mycophenolate mofetil) Capsules, Roche Palo, Labeling Revision
CellCept (mycophenolate mofetil) Tablets, Roche Palo, Labeling Revision
CellCept (mycophenolate mofetil hydrochloride), Intravenous, Roche Palo,
Labeling Revision
CellCept (mycophenolate mofetil) Oral Suspension, Roche Palo, Labeling
Revision
Fludarabine Phosphate Injection, Ebewe Pharma, Approval
Hydroxychloroquine Sulfate Tablets, Zydus Pharma, Approval
Prednisolone Syrup, Vintage Pharma, Approval
Ranitidine Syrup, Pharmaceutical Assoc. Inc., Approval
Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)
TWC Global LLC, Inc., issues a recall of Axcil and Desirin, both
marketed as dietary supplements, because they contain undeclared analogs
of sildenafil. MedWatch Safety Information
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Axcil
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posted by Mags @ 9:55 AM,
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