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,
