CDERNEW-TEXT 9/13/2007
Friday, September 14, 2007
September 13, 2007
Approved Drug Products with Therapeutic Equivalence Evaluations Orange
Book http://www.fda.gov/cder/orange/default.htm
Fentora (fentanyl buccal tablet)
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora
- Cephalon
issues two Dear Healthcare Professional Letters to inform prescribers
and other healthcare providers of important safety information regarding
Fentora.
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Amlodipine Besylate Tablets, Lek Pharma, Approval
Cefazolin Injection, USP and Dextrose Injection, USP in the Duplex
Container, B. Braun Medical, Labeling Revision
Cefuroxime Injection and Dextrose Injection in the Duplex Container, B.
Braun Medical, Labeling Revision
Colgate Total (sodium fluoride and triclosan dentifrice) Toothpaste,
Colgate-Palmolive, Formulation Revision
Griseofulvin Oral Suspension, Ivax Pharma, Approval
Humulin R (insulin [rDNA origin]) Human Injection, Eli Lilly, Labeling
Revision
Ibuprofen Tablets, Northstar Healthcare, Approval
Lamotrigine Tablets, Dr. Reddy's Labs, Tentative Approval
Lamotrigine Chewable Tablets, Dr. Reddy's Labs, Tentative Approval
Levaquin (levofloxacin) Tablets, Ortho-McNeil Pharma, Patient Population
Altered
Levaquin (levofloxacin) Injection and Levaquin (levofloxacin in
dextrose) Injection, Ortho-McNeil Pharma, Patient Population Altered
Levaquin (levofloxacin) Oral Solution, Ortho-McNeil Pharma, Patient
Population Altered
Motrin (ibuprofen) Tablets, McNeil Pediatrics, Labeling Revision
Motrin (ibuprofen) Suspension, McNeil Pediatrics, Labeling Revision
Pantoprazole Sodium Delayed Release Tablet, Sun Pharma, Approval
Septra and Septra DS (trimethoprim/sulfamethoxazole) Tablets, Monarch
Pharma, Labeling Revision
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posted by Mags @ 9:36 AM,
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CDERNEW-TEXT 9/12/2007
Wednesday, September 12, 2007
September 12, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
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posted by Mags @ 5:46 PM,
,
CDERNEW-TEXT 9/11/2007
Tuesday, September 11, 2007
September 11, 2007
FDA issues an FDA Alert and Healthcare Professional sheet for Rocephin
(ceftriaxone) clarifying concomitant use with calcium-containing
products or solutions. Drug Information
http://www.fda.gov/cder/drug/infopage/ceftriaxone/default.htm
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Carvedilol Tablets, Hikma Pharma, Approval
Cefotaxime Injection and Dextrose Injection, B. Braun Medical, Inc.,
Labeling Revision
Cromolyn Sodium Nasal Solution, QPharma, Approval
Tricor (fenofibrate) Tablets, Abbott Labs, Labeling Revision
Zolpidem Tartrate Tablets, Invagen Pharma, Approval
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posted by Mags @ 4:25 PM,
,
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,
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