CDERNEW-TEXT 9/10/2007
Monday, September 10, 2007
September 10, 2007
CDER on CMC: 21st Century Pharmaceutical Manufacturing and Control
Strategies - A Changing Paradigm, October 15-16, 2007 Bethesda North
Marriott Hotel & Conference Center. Meeting information
http://www.aapspharmaceutica.com/meetings/pharmaFDAweb.html
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Actos (pioglitazone HCl) Tablets, Takeda Global Research, Labeling
Revision
Alimta (pemetrexed) Injection, Eli Lilly & Co., Control Supplement
Humulin R (insulin human injection, USP [rDNA origin]), Eli Lilly & Co.,
Labeling Revision
Humulin N NPH (human insulin isophane suspension [rDNA origin]), Eli
Lilly & Co., Labeling Revision
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human
injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision
Humulin 50/50 (50% human insulin isophane suspension/50% insulin human
injection, [rDNA origin]), Eli Lilly & Co., Labeling Revision
Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co.,
Labeling Revision
Humalog (insulin lispro injection [rDNA origin]), Eli Lilly & Co.,
Package Change
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Package Change
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Labeling Revision
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin
lispro injection [rDNA origin]), Eli Lilly & Co., Package Change
RELENZA (zanamivir) Inhalation, GlaxoSmithKline, Labeling Revision
Sectral (acebutolol hydrochloride) Capsules, Dr. Reddy's Labs, Labeling
Revision
Topiramate Tablets, Aurobindo Pharma, Tentative Approval
Totect (dexrazoxane) Injection, TopoTarget Inc., Approval
Pfizer issues a Dear Healthcare Professional Letter to inform healthcare
professionals of the presence of ethyl methanesulfonate in Viracept
(nelfinavir mesylate). MedWatch Safety Information
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Viracept
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posted by Mags @ 6:03 PM,
