CDERNEW-TEXT 9/18/2007
Wednesday, September 19, 2007
September 18, 2007
Approved Active Moieties That Have Appeared On The National Institutes
Of Health's (NIH) Annual Priority List For Which FDA Has Issued A
Written Request For Pediatric Studies Under The Best Pharmaceuticals For
Children Act (BPCA) http://www.fda.gov/cder/pediatric/offpatwrlist.htm
(updated)
FDA launches the first issue of the FDA Drug Safety Newsletter
http://www.fda.gov/cder/dsn/default.htm , a publication for healthcare
professionals and the medical community.
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
CEFZIL (cefprozil) Tablets, Bristol-Myers Squibb, Labeling Revision
CEFZIL (cefprozil) Oral Suspension, Bristol-Myers Squibb, Labeling
Revision
Evista (raloxifene hydrochloride) Tablets, Eli Lilly, Approval
Gleevec (imatinib mesylate) Ttablets, Novartis Pharma, Efficacy Suppl.
w/Clinical Data
Imodium Advance (loperamide HCl and simethicone) Caplets, McNeil
Consumer, Formulation Revision
Lamotrigine Tablets, Zydus Pharma, Tentative Approval
Macrodantin (nitrofurantoin macrocrystals) Capsules, Proctor and Gamble,
Labeling Revision
MAXIPIME (cefepime hydrochloride) Powder for Injection, Bristol-Myers
Squibb, Labeling Revision
OMNICEF (cefdinir) Capsules, Abbott Labs, Labeling Revision
OMNICEF (cefdinir) Oral Suspension, Abbott Labs, Labeling Revision
SOMA (carisoprodol) Tablets, Medpointe Pharma, New Dosage Regimen
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posted by Mags @ 1:12 PM,
