CDERNEW-TEXT 10/15/2007
Tuesday, October 16, 2007
October 15, 2007
FDA Acronyms Search
http://www.accessdata.fda.gov/scripts/cder/acronyms/index.cfm
(updated)
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Delestrogen (estradiol valerate) Injection, JHP Pharma, Manufacturing
Change or Addition
Doribax (doripenem) Injection, Johnson & Johnson, Approval
Isentress (raltegravir) Tablets, Merck & Co., Approval
Januvia (sitagliptin) Tablets, Merck & Co., New or Modified Indication
LEXIVA (fosamprenavir calcium; FPV) Oral Tablets, GlaxoSmithKline, New
Dosage Regimen
Lodine (etodolac) Capsules and Tablets, Wyeth Pharma, Labeling Revision
Nateglinide Tablets, Watson Labs, Tentative Approval
Oxcarbazepine Tablets, Apotex, Tentative Approval
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posted by Mags @ 5:09 AM,
