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
------------------------------------------------
To subscribe or to unsubscribe from CDERNEW-TEXT
http://list.nih.gov/archives/cdernew-text.html
------------------------------------------------
posted by Mags @ 9:36 AM,
